Regulation (EU) 2017/745 on medical devices
3 corrections name this row · last → history
Of the 12 rungs of this entry’s evidence ladder: 8 held · 2 held in part · 1 read, and not there · 1 nothing held.
A rung marked nothing held has no recorded reading; one marked read, and not there has a reading that ran and did not find it. Rungs stand in the ladder’s fixed order and the counts in this fixed order of marks: held · held in part · read, and not there · nothing held; neither order says anything about this entry. The counts on /coverage are counted by rules of their own, so a rung here and a count there of one name can differ. The sentence behind each mark is in the evidence ladder, under Evidence.
No conclusion is drawn from absence. An absence here is not evidence that a document does not exist, is not in force, or does not govern.
Of the 12 rungs on this entry, 8 are held, 2 are held in part under a limit each one states, and 2 cannot be established from what this record holds. Each of those carries the reading that produced it and whose blank it is. Ordered by whose blank each names: this record’s own first, then the publisher’s, then the blanks this record cannot attribute at all.
1 this record has not looked — no reading of this rung is recorded here. The blank is this record’s, and it is not evidence about the publisher · 1 this record cannot tell which — what is held does not say whether the blank is the publisher’s or this record’s. This is an absence of an attribution, not a kind of one
Established for this entry: identity · publisher · jurisdiction · type · current edition · observation history · text · verification. Held in part: publication date · diff.
The reading behind every one of those is stated rung by rung in the evidence ladder under Evidence, and the public evidence each was marked from is published in full on this page under Timeline, Publisher neighbourhood, Observation history and Sources.
What this record undertakes for this entry is stated in 6 terms, each answering one question, and each answered for this entry in the coverage contract under Evidence:
Open primary source (opens in new tab) eur-lex.europa.eu View observation 2026-11-02 · sequence 1
Document status what the publisher asserts, and the status recorded here
Publisher lifecycle field: none captured
No status read is recorded for this entry — this record has not read a publisher surface for its status, which is a fact about this record and not about the publisher. A status read is recorded for 7 of 132 tracked entries, 5 of which banked a passage.
Recorded status: in force as of 26 May 2020 (basis: the act named under Established by)
Verification what a person or a tool has confirmed here, and when
Evidence state what this record holds
verified by a person — a person checked this entry against the primary source on a recorded day
/api/v1/instruments.json.
Filed core. For that label this archive undertakes to close an entry's open status question by rule on a clock, with its reason, and to re-read a ratification on record against its observation every night. The label records what this archive undertakes for a class of entries. It states no finding about this one, and it is not a ranking.
Access: no robots.txt published
Resolution: direct document
The dated facts this record holds for this entry. Each line below states what one kind of dated fact amounts to here, and links to the list holding it where this entry has one; the list carries the dates, the words and the addresses they were read from. Nothing is counted twice: where a line states a number, the section it names states none.
What is not published. This build serves 3 address(es) holding
a time-ordered list for an entry — a TimeMap in JSON, its
link-format sibling and an index — each expanding to one
document per tracked entry. What they list is CAPTURES of this
entry’s source held at a web archive, carrying that
archive’s own capture instants; this record serves no copy of
a tracked document, so none of those addresses is one of this
record’s, and a capture address is published only where the
terms filing recorded for the source host permits it. This
entry’s own is at /api/v1/timemap/eu-mdr.json.
The route set naming them, and what each one answers, is published
at /developers.
| Date | Event | Confidence | Source |
|---|---|---|---|
| 2020-05-26 | effective date EU MDR recorded as in force as of this date | confirmed | link (opens in new tab) |
What sits around this entry, counted. Every figure below is drawn from a value already rendered elsewhere on this page; where a count has a list, the count is here and the list stays in the section holding its evidence.
| Window | Observations of the document | Of those, carrying a digest | Of those, carrying a change | Direct document | Official signals dated inside it |
|---|---|---|---|---|---|
| 30 calendar days | 31 | 3 | 0 | no detected difference in window | not measured |
| 90 calendar days | 140 | 47 | 0 | no detected difference in window | not measured |
| 365 calendar days | 193 | 82 | 0 | no detected difference in window | not measured |
A window is marked changed where at least one observation of the document inside it recorded a change against the previous one; unchanged where the window holds at least one such observation, at least one of them carries a digest of the retrieved bytes, and none recorded a change; undigested where the window holds observations and none of them carries a digest, so no observation in it could be compared with another; and unmeasured where the window holds no observation at all. The word is shorthand for the three counts printed beside it and adds nothing to them. It is a statement about the window and never about the document outside it, which is why a window reaching back before the first observation says so underneath. A mark is derived from the observations a window holds and never from the days it spans; which days inside this entry’s own window hold none is stated by the coverage sentence in Observation history below.
The first observation of the document this entry names is . These windows reach back before it — 365 calendar days — so part of the span each names was never watched, and a window with no detected difference inside it says nothing about the days before that first observation.
no detected difference in window — this window holds observations of the document and none of them recorded a change — which is a statement about the window, not about the document outside it
No word is attached to the signal count beside it, and none will be. Any word for the size of a count needs either a threshold this record would have authored or a comparison against other entries that would rank the sources against one another; the count and its window are the whole claim. The document column beside it carries a word only because the rule reaching it is printed underneath and can be checked against the counts it stands for.
The last column holds no member on this entry. The zero it holds is named under “Around it” below.
topic.medical-devices. The record’s day is , and this entry holds 1 publisher-dated lifecycle fact(s): 1 falling before that day, 0 on it and 0 after it.
Next holds the publisher-dated facts this record already carries that fall after the day this record calls today — a stated effective date, a consultation close. Nothing is projected and no step is inferred from a lifecycle: where a publisher has stated no further date, the cell says so, and what is absent is a statement rather than a future.
The words this document uses about itself, matched verbatim against its own title. Not a statement of scope, and not a judgment about which organisations or products fall under it: each value quotes the span it was read from and links to where that span was read.
One document's retained text contained a form another document is published under, on the date shown, with the words it was read from. An edge cannot tell the manner of a citation — a document naming another in order to exclude it produces the same entry as one adopting it.
publisher-stated citation relationships — not a regulatory applicability determination The policy, stated once
These citations are drawn together on the citation graph, where every row carries the same quote and source.
A family forms only along a supersedes, superseded-by or document-history line a publisher prints. A shared title, number, date or prefix forms none. This records what one document's publisher lists about another and states nothing about the relationship between their requirements.
In no family. No store this record fills holds a supersedes, superseded-by or document-history field naming a second document for this entry, so whether its publisher prints such a line is unmeasured.
Recorded as in-force against the primary source on 28 July 2026.
The supporting text is not reproduced here. The banked passage concerns common specifications and Member States' measures, and no span within it states a status for this Regulation. It was retrieved 28 July 2026 by browser and is at the location below, in the primary source.
Found at: character offset 58298
What this record holds for this entry, rung by rung, each mark derived from a field, a count or a stored reading. Rungs in the order the record acquires them, from what an entry is to what has been checked about it. The order is fixed; a rung’s position says nothing about any entry.
✓ held — this record holds it, and the sentence beside it names what from · △ held in part — part of it is held, or it is held under a limit the sentence states · — nothing held — no reading of this rung is recorded — nobody has looked, which is not the same as looking and finding nothing · ✗ read, and not there — a reading ran and did not find it — an absence this record measured
The first rung a reading ran on and did not find: publisher notices — A collection of publisher notices has succeeded and none of the records it holds attaches to this entry.
All 8 evidence states, marked against this entry’s own fields. The axis at the top of this page publishes the first of them this entry meets; a state it meets after that is marked as met and not carried, because a state an entry meets and does not carry is not the same fact as one it fails. 7 of the 8 come from the published model and 1 was recorded here. The order, and why it is not a ranking, is stated on the observatory.
◆ carried — the entry meets this test and no state before it in the order does, so this is the state its evidence axis publishes · ◇ also true — the entry meets this test as well, and the axis publishes a state that comes before it in the order · × not met — the entry does not meet this test, and the line beside it names what was read
Each term states what this record does for this entry and what it does not, derived from the entry’s own fields and its own series. It is a record of coverage, not a finding about the document.
render_mode The page is assembled in the browser, so its content is not present in the markup this record retrieves.The test an entry is admitted under is published in full, with its negative limb and its worked examples, at the inclusion rule. What this record holds about THIS entry's admission is below, each line naming the store it was read from.
Observed on 193 occasion(s) since 2026-07-28.
82 produced a content hash. No observation is marked !
(digest differed).
~~~·~~············~~~···××·········~~~~~··~·····~··~·~~·~~~~······~····~~~···~··~~~~~~~··~~·~···~~~~~~~···~~~~·~~·~··~~~·~~··········×~~~~~··~~~~~~·~~~~~·~~~~~~~~~~~~~~··×~~~~~~·~~~~~~~~~~~~~~~
All 193 marks, one per observation, oldest first. · unchanged · ! digest differed ·
~ fetched but rendered client-side, no hash ·
× could not be fetched, no hash ·
/ withheld by the publisher’s terms — no fetch made.
Every one of the 98 days from 2026-07-28 to 2026-11-02 holds an observation.
Each mark links to the single observation it stands for, at
that observation’s own address. The whole series, with every address, is at /observations/eu-mdr.
Any two of its retained observations can be set side by side at /compare/eu-mdr.
The same evidence as a packet, with its refusals and its
integrity reference, is at /packet/eu-mdr.
Every observation in this series is published, untruncated, at /api/v1/observations.json.
Of the retrievals classified as this document: same digest on 19 observed days, 2026-08-11 to 2026-10-18 (33 retrievals); 50 of the 69 calendar days in that span hold no digest of this document and are not counted; the last digest before it, recorded on 2026-08-10, differs; 15 later observed days hold no digest of this document. This states what this record retrieved and normalised on those days, and nothing about the document on any other day.
! (digest differed): 0 · first observed: 2026-07-28 2026-11-02·1. /observations/eu-mdr — every record of this row, with its address. /api/v1/series.jsonl — the same records for every row, one line each.
Each observation is addressed by this row’s identifier, the date it was observed, and its sequence within that date — the same key /api/v1/series.jsonl publishes as `sequence`, counted in the order the store recorded them.
Each string below is the string served for this entry at
/api/v1/clause-anchors.json,
/api/v1/definitions.json and
/api/v1/modal-sentences.json,
one block per observed text, each named by the first 12 characters of its
content_hash as the JSON serves it: each clause anchor's id beside its label as the text prints it,
each definition's term with its text where the derivation quotes it, and each sentence printing
a listed verb that sits under the quote cap. A sentence or definition text over the cap is not
cut: it is cited by the clause anchor it sits under, or by the stored reason no anchor is
placed, its text withheld, and the count withheld is printed beside the count read. The block
of the current text, where one is marked, is the one shown open.
14d00b77d5c8, first observed 2026-07-28Clause anchors: read; 1000 placed and 0 withheld.
chapter-i CHAPTER Ichapter-i/article-1 Article 1chapter-i/article-1/1 1.chapter-i/article-1/2 2.chapter-i/article-1/3 3.chapter-i/article-1/4 4.chapter-i/article-1/5 5.chapter-i/article-1/6 6.chapter-i/article-1/7 7.chapter-i/article-1/8 8.chapter-i/article-1/9 9.chapter-i/article-1/10 10.chapter-i/article-1/11 11.chapter-i/article-1/12 12.chapter-i/article-1/13 13.chapter-i/article-1/14 14.chapter-i/article-1/15 15.chapter-i/article-1/16 16.chapter-i/article-2 Article 2chapter-i/article-3 Article 3chapter-i/article-4 Article 4chapter-i/article-4/1 1.chapter-i/article-4/2 2.chapter-i/article-4/3 3.chapter-i/article-4/4 4.chapter-ii CHAPTER IIchapter-ii/article-5 Article 5chapter-ii/article-5/1 1.chapter-ii/article-5/2 2.chapter-ii/article-5/3 3.chapter-ii/article-5/4 4.chapter-ii/article-5/5 5.chapter-ii/article-5/6 6.chapter-ii/article-6 Article 6chapter-ii/article-6/1 1.chapter-ii/article-6/2 2.chapter-ii/article-6/3 3.chapter-ii/article-6/4 4.chapter-ii/article-7 Article 7chapter-ii/article-8 Article 8chapter-ii/article-8/1 1.chapter-ii/article-8/2 2.chapter-ii/article-9 Article 9chapter-ii/article-9/1 1.chapter-ii/article-9/2 2.chapter-ii/article-9/3 3.chapter-ii/article-9/4 4.chapter-ii/article-10 Article 10chapter-ii/article-10/1 1.chapter-ii/article-10/2 2.chapter-ii/article-10/3 3.chapter-ii/article-10/4 4.chapter-ii/article-10/5 5.chapter-ii/article-10/6 6.chapter-ii/article-10/7 7.chapter-ii/article-10/8 8.chapter-ii/article-10/9 9.chapter-ii/article-10/10 10.chapter-ii/article-10/11 11.chapter-ii/article-10/12 12.chapter-ii/article-10/13 13.chapter-ii/article-10/14 14.chapter-ii/article-10/15 15.chapter-ii/article-10/16 16.chapter-ii/article-11 Article 11chapter-ii/article-11/1 1.chapter-ii/article-11/2 2.chapter-ii/article-11/3 3.chapter-ii/article-11/4 4.chapter-ii/article-11/5 5.chapter-ii/article-11/6 6.chapter-ii/article-11/7 7.chapter-ii/article-12 Article 12chapter-ii/article-13 Article 13chapter-ii/article-13/1 1.chapter-ii/article-13/2 2.chapter-ii/article-13/3 3.chapter-ii/article-13/4 4.chapter-ii/article-13/5 5.chapter-ii/article-13/6 6.chapter-ii/article-13/7 7.chapter-ii/article-13/8 8.chapter-ii/article-13/9 9.chapter-ii/article-13/10 10.chapter-ii/article-14 Article 14chapter-ii/article-14/1 1.chapter-ii/article-14/2 2.chapter-ii/article-14/3 3.chapter-ii/article-14/4 4.chapter-ii/article-14/5 5.chapter-ii/article-14/6 6.chapter-ii/article-15 Article 15chapter-ii/article-15/1 1.chapter-ii/article-15/2 2.chapter-ii/article-15/3 3.chapter-ii/article-15/4 4.chapter-ii/article-15/5 5.chapter-ii/article-15/6 6.chapter-ii/article-16 Article 16chapter-ii/article-16/1 1.chapter-ii/article-16/2 2.chapter-ii/article-16/3 3.chapter-ii/article-16/4 4.chapter-ii/article-17 Article 17chapter-ii/article-17/1 1.chapter-ii/article-17/2 2.chapter-ii/article-17/3 3.chapter-ii/article-17/4 4.chapter-ii/article-17/5 5.chapter-ii/article-17/6 6.chapter-ii/article-17/7 7.chapter-ii/article-17/8 8.chapter-ii/article-17/9 9.chapter-ii/article-17/10 10.chapter-ii/article-18 Article 18chapter-ii/article-18/1 1.chapter-ii/article-18/2 2.chapter-ii/article-18/3 3.chapter-ii/article-19 Article 19chapter-ii/article-19/1 1.chapter-ii/article-19/2 2.chapter-ii/article-19/3 3.chapter-ii/article-19/4 4.chapter-ii/article-20 Article 20chapter-ii/article-20/1 1.chapter-ii/article-20/2 2.chapter-ii/article-20/3 3.chapter-ii/article-20/4 4.chapter-ii/article-20/5 5.chapter-ii/article-20/6 6.chapter-ii/article-21 Article 21chapter-ii/article-21/1 1.chapter-ii/article-21/2 2.chapter-ii/article-21/3 3.chapter-ii/article-22 Article 22chapter-ii/article-22/1 1.chapter-ii/article-22/2 2.chapter-ii/article-22/3 3.chapter-ii/article-22/4 4.chapter-ii/article-22/5 5.chapter-ii/article-23 Article 23chapter-ii/article-23/1 1.chapter-ii/article-23/2 2.chapter-ii/article-24 Article 24chapter-iii CHAPTER IIIchapter-iii/article-25 Article 25chapter-iii/article-25/1 1.chapter-iii/article-25/2 2.chapter-iii/article-26 Article 26chapter-iii/article-27 Article 27chapter-iii/article-27/1 1.chapter-iii/article-27/2 2.chapter-iii/article-27/3 3.chapter-iii/article-27/4 4.chapter-iii/article-27/5 5.chapter-iii/article-27/6 6.chapter-iii/article-27/7 7.chapter-iii/article-27/8 8.chapter-iii/article-27/9 9.chapter-iii/article-27/10 10.chapter-iii/article-27/11 11.chapter-iii/article-27/12 12.chapter-iii/article-28 Article 28chapter-iii/article-28/1 1.chapter-iii/article-28/2 2.chapter-iii/article-28/3 3.chapter-iii/article-28/4 4.chapter-iii/article-29 Article 29chapter-iii/article-29/1 1.chapter-iii/article-29/2 2.chapter-iii/article-29/3 3.chapter-iii/article-29/4 4.chapter-iii/article-30 Article 30chapter-iii/article-30/1 1.chapter-iii/article-30/2 2.chapter-iii/article-30/3 3.chapter-iii/article-31 Article 31chapter-iii/article-31/1 1.chapter-iii/article-31/2 2.chapter-iii/article-31/3 3.chapter-iii/article-31/4 4.chapter-iii/article-31/5 5.chapter-iii/article-31/6 6.chapter-iii/article-31/7 7.chapter-iii/article-31/8 8.chapter-iii/article-32 Article 32chapter-iii/article-32/1 1.chapter-iii/article-32/2 2.chapter-iii/article-32/3 3.chapter-iii/article-33 Article 33chapter-iii/article-33/1 1.chapter-iii/article-33/2 2.chapter-iii/article-33/3 3.chapter-iii/article-33/4 4.chapter-iii/article-33/5 5.chapter-iii/article-33/6 6.chapter-iii/article-33/7 7.chapter-iii/article-33/8 8.chapter-iii/article-33/9 9.chapter-iii/article-34 Article 34chapter-iii/article-34/1 1.chapter-iii/article-34/2 2.chapter-iii/article-34/3 3.chapter-iv CHAPTER IVchapter-iv/article-35 Article 35chapter-iv/article-35/1 1.chapter-iv/article-35/2 2.chapter-iv/article-35/3 3.chapter-iv/article-35/4 4.chapter-iv/article-35/5 5.chapter-iv/article-35/6 6.chapter-iv/article-35/7 7.chapter-iv/article-35/8 8.chapter-iv/article-36 Article 36chapter-iv/article-36/1 1.chapter-iv/article-36/2 2.chapter-iv/article-36/3 3.chapter-iv/article-37 Article 37chapter-iv/article-37/1 1.chapter-iv/article-37/2 2.chapter-iv/article-37/3 3.chapter-iv/article-37/4 4.chapter-iv/article-37/5 5.chapter-iv/article-38 Article 38chapter-iv/article-38/1 1.chapter-iv/article-38/2 2.chapter-iv/article-38/3 3.chapter-iv/article-39 Article 39chapter-iv/article-39/1 1.chapter-iv/article-39/2 2.chapter-iv/article-39/3 3.chapter-iv/article-39/4 4.chapter-iv/article-39/5 5.chapter-iv/article-39/6 6.chapter-iv/article-39/7 7.chapter-iv/article-39/8 8.chapter-iv/article-39/9 9.chapter-iv/article-39/10 10.chapter-iv/article-40 Article 40chapter-iv/article-40/1 1.chapter-iv/article-40/2 2.chapter-iv/article-41 Article 41chapter-iv/article-42 Article 42chapter-iv/article-42/1 1.chapter-iv/article-42/2 2.chapter-iv/article-42/3 3.chapter-iv/article-42/4 4.chapter-iv/article-42/5 5.chapter-iv/article-42/6 6.chapter-iv/article-42/7 7.chapter-iv/article-42/8 8.chapter-iv/article-42/9 9.chapter-iv/article-42/10 10.chapter-iv/article-42/11 11.chapter-iv/article-42/12 12.chapter-iv/article-42/13 13.chapter-iv/article-43 Article 43chapter-iv/article-43/1 1.chapter-iv/article-43/2 2.chapter-iv/article-44 Article 44chapter-iv/article-44/1 1.chapter-iv/article-44/2 2.chapter-iv/article-44/3 3.chapter-iv/article-44/4 4.chapter-iv/article-44/5 5.chapter-iv/article-44/6 6.chapter-iv/article-44/7 7.chapter-iv/article-44/8 8.chapter-iv/article-44/9 9.chapter-iv/article-44/10 10.chapter-iv/article-44/11 11.chapter-iv/article-44/12 12.chapter-iv/article-45 Article 45chapter-iv/article-45/1 1.chapter-iv/article-45/2 2.chapter-iv/article-45/3 3.chapter-iv/article-45/4 4.chapter-iv/article-45/5 5.chapter-iv/article-45/6 6.chapter-iv/article-46 Article 46chapter-iv/article-46/1 1.chapter-iv/article-46/2 2.chapter-iv/article-46/3 3.chapter-iv/article-46/4 4.chapter-iv/article-46/5 5.chapter-iv/article-46/6 6.chapter-iv/article-46/7 7.chapter-iv/article-46/8 8.chapter-iv/article-46/9 9.chapter-iv/article-47 Article 47chapter-iv/article-47/1 1.chapter-iv/article-47/2 2.chapter-iv/article-47/3 3.chapter-iv/article-47/4 4.chapter-iv/article-47/5 5.chapter-iv/article-48 Article 48chapter-iv/article-48/1 1.chapter-iv/article-48/2 2.chapter-iv/article-48/3 3.chapter-iv/article-48/4 4.chapter-iv/article-48/5 5.chapter-iv/article-49 Article 49chapter-iv/article-50 Article 50chapter-v CHAPTER Vchapter-v/section-1 SECTION 1chapter-v/section-1/article-51 Article 51chapter-v/section-1/article-51/1 1.chapter-v/section-1/article-51/2 2.chapter-v/section-1/article-51/3 3.chapter-v/section-1/article-51/4 4.chapter-v/section-1/article-51/5 5.chapter-v/section-1/article-51/6 6.chapter-v/section-2 SECTION 2chapter-v/section-2/article-52 Article 52chapter-v/section-2/article-52/1 1.chapter-v/section-2/article-52/2 2.chapter-v/section-2/article-52/3 3.chapter-v/section-2/article-52/4 4.chapter-v/section-2/article-52/5 5.chapter-v/section-2/article-52/6 6.chapter-v/section-2/article-52/7 7.chapter-v/section-2/article-52/8 8.chapter-v/section-2/article-52/9 9.chapter-v/section-2/article-52/10 10.chapter-v/section-2/article-52/11 11.chapter-v/section-2/article-52/12 12.chapter-v/section-2/article-52/13 13.chapter-v/section-2/article-52/14 14.chapter-v/section-2/article-53 Article 53chapter-v/section-2/article-53/1 1.chapter-v/section-2/article-53/2 2.chapter-v/section-2/article-53/3 3.chapter-v/section-2/article-53/4 4.chapter-v/section-2/article-53/5 5.chapter-v/section-2/article-54 Article 54chapter-v/section-2/article-54/1 1.chapter-v/section-2/article-54/2 2.chapter-v/section-2/article-54/3 3.chapter-v/section-2/article-54/4 4.chapter-v/section-2/article-54/5 5.chapter-v/section-2/article-55 Article 55chapter-v/section-2/article-55/1 1.chapter-v/section-2/article-55/2 2.chapter-v/section-2/article-55/3 3.chapter-v/section-2/article-56 Article 56chapter-v/section-2/article-56/1 1.chapter-v/section-2/article-56/2 2.chapter-v/section-2/article-56/3 3.chapter-v/section-2/article-56/4 4.chapter-v/section-2/article-56/5 5.chapter-v/section-2/article-56/6 6.chapter-v/section-2/article-57 Article 57chapter-v/section-2/article-57/1 1.chapter-v/section-2/article-57/2 2.chapter-v/section-2/article-58 Article 58chapter-v/section-2/article-58/1 1.chapter-v/section-2/article-58/2 2.chapter-v/section-2/article-59 Article 59chapter-v/section-2/article-59/1 1.chapter-v/section-2/article-59/2 2.chapter-v/section-2/article-59/3 3.chapter-v/section-2/article-60 Article 60chapter-v/section-2/article-60/1 1.chapter-v/section-2/article-60/2 2.chapter-vi CHAPTER VIchapter-vi/article-61 Article 61chapter-vi/article-61/1 1.chapter-vi/article-61/2 2.chapter-vi/article-61/3 3.chapter-vi/article-61/4 4.chapter-vi/article-61/5 5.chapter-vi/article-61/6 6.chapter-vi/article-61/7 7.chapter-vi/article-61/8 8.chapter-vi/article-61/9 9.chapter-vi/article-61/10 10.chapter-vi/article-61/11 11.chapter-vi/article-61/12 12.chapter-vi/article-61/13 13.chapter-vi/article-62 Article 62chapter-vi/article-62/1 1.chapter-vi/article-62/2 2.chapter-vi/article-62/3 3.chapter-vi/article-62/4 4.chapter-vi/article-62/5 5.chapter-vi/article-62/6 6.chapter-vi/article-62/7 7.chapter-vi/article-63 Article 63chapter-vi/article-63/1 1.chapter-vi/article-63/2 2.chapter-vi/article-63/3 3.chapter-vi/article-63/4 4.chapter-vi/article-63/5 5.chapter-vi/article-63/6 6.chapter-vi/article-63/7 7.chapter-vi/article-64 Article 64chapter-vi/article-64/1 1.chapter-vi/article-64/2 2.chapter-vi/article-65 Article 65chapter-vi/article-66 Article 66chapter-vi/article-67 Article 67chapter-vi/article-68 Article 68chapter-vi/article-68/1 1.chapter-vi/article-68/2 2.chapter-vi/article-68/3 3.chapter-vi/article-69 Article 69chapter-vi/article-69/1 1.chapter-vi/article-69/2 2.chapter-vi/article-70 Article 70chapter-vi/article-70/1 1.chapter-vi/article-70/2 2.chapter-vi/article-70/3 3.chapter-vi/article-70/4 4.chapter-vi/article-70/5 5.chapter-vi/article-70/6 6.chapter-vi/article-70/7 7.chapter-vi/article-70/8 8.chapter-vi/article-70/9 9.chapter-vi/article-71 Article 71chapter-vi/article-71/1 1.chapter-vi/article-71/2 2.chapter-vi/article-71/3 3.chapter-vi/article-71/4 4.chapter-vi/article-72 Article 72chapter-vi/article-72/1 1.chapter-vi/article-72/2 2.chapter-vi/article-72/3 3.chapter-vi/article-72/4 4.chapter-vi/article-72/5 5.chapter-vi/article-72/6 6.chapter-vi/article-73 Article 73chapter-vi/article-73/1 1.chapter-vi/article-73/2 2.chapter-vi/article-73/3 3.chapter-vi/article-73/4 4.chapter-vi/article-73/5 5.chapter-vi/article-74 Article 74chapter-vi/article-74/1 1.chapter-vi/article-74/2 2.chapter-vi/article-75 Article 75chapter-vi/article-75/1 1.chapter-vi/article-75/2 2.chapter-vi/article-75/3 3.chapter-vi/article-75/4 4.chapter-vi/article-76 Article 76chapter-vi/article-76/1 1.chapter-vi/article-76/2 2.chapter-vi/article-76/3 3.chapter-vi/article-76/4 4.chapter-vi/article-77 Article 77chapter-vi/article-77/1 1.chapter-vi/article-77/2 2.chapter-vi/article-77/3 3.chapter-vi/article-77/4 4.chapter-vi/article-77/5 5.chapter-vi/article-77/6 6.chapter-vi/article-77/7 7.chapter-vi/article-78 Article 78chapter-vi/article-78/1 1.chapter-vi/article-78/2 2.chapter-vi/article-78/3 3.chapter-vi/article-78/4 4.chapter-vi/article-78/5 5.chapter-vi/article-78/6 6.chapter-vi/article-78/7 7.chapter-vi/article-78/8 8.chapter-vi/article-78/9 9.chapter-vi/article-78/10 10.chapter-vi/article-78/11 11.chapter-vi/article-78/12 12.chapter-vi/article-78/13 13.chapter-vi/article-78/14 14.chapter-vi/article-79 Article 79chapter-vi/article-80 Article 80chapter-vi/article-80/1 1.chapter-vi/article-80/2 2.chapter-vi/article-80/3 3.chapter-vi/article-80/4 4.chapter-vi/article-80/5 5.chapter-vi/article-80/6 6.chapter-vi/article-81 Article 81chapter-vi/article-82 Article 82chapter-vi/article-82/1 1.chapter-vi/article-82/2 2.chapter-vii CHAPTER VIIchapter-vii/section-1 SECTION 1chapter-vii/section-1/article-83 Article 83chapter-vii/section-1/article-83/1 1.chapter-vii/section-1/article-83/2 2.chapter-vii/section-1/article-83/3 3.chapter-vii/section-1/article-83/4 4.chapter-vii/section-1/article-84 Article 84chapter-vii/section-1/article-85 Article 85chapter-vii/section-1/article-86 Article 86chapter-vii/section-1/article-86/1 1.chapter-vii/section-1/article-86/2 2.chapter-vii/section-1/article-86/3 3.chapter-vii/section-2 SECTION 2chapter-vii/section-2/article-87 Article 87chapter-vii/section-2/article-87/1 1.chapter-vii/section-2/article-87/2 2.chapter-vii/section-2/article-87/3 3.chapter-vii/section-2/article-87/4 4.chapter-vii/section-2/article-87/5 5.chapter-vii/section-2/article-87/6 6.chapter-vii/section-2/article-87/7 7.chapter-vii/section-2/article-87/8 8.chapter-vii/section-2/article-87/9 9.chapter-vii/section-2/article-87/10 10.chapter-vii/section-2/article-87/11 11.chapter-vii/section-2/article-88 Article 88chapter-vii/section-2/article-88/1 1.chapter-vii/section-2/article-88/2 2.chapter-vii/section-2/article-89 Article 89chapter-vii/section-2/article-89/1 1.chapter-vii/section-2/article-89/2 2.chapter-vii/section-2/article-89/3 3.chapter-vii/section-2/article-89/4 4.chapter-vii/section-2/article-89/5 5.chapter-vii/section-2/article-89/6 6.chapter-vii/section-2/article-89/7 7.chapter-vii/section-2/article-89/8 8.chapter-vii/section-2/article-89/9 9.chapter-vii/section-2/article-89/10 10.chapter-vii/section-2/article-89/11 11.chapter-vii/section-2/article-90 Article 90chapter-vii/section-2/article-91 Article 91chapter-vii/section-2/article-92 Article 92chapter-vii/section-2/article-92/1 1.chapter-vii/section-2/article-92/2 2.chapter-vii/section-2/article-92/3 3.chapter-vii/section-2/article-92/4 4.chapter-vii/section-2/article-92/5 5.chapter-vii/section-2/article-92/6 6.chapter-vii/section-2/article-92/7 7.chapter-vii/section-2/article-92/8 8.chapter-vii/section-2/article-92/9 9.chapter-vii/section-3 SECTION 3chapter-vii/section-3/article-93 Article 93chapter-vii/section-3/article-93/1 1.chapter-vii/section-3/article-93/2 2.chapter-vii/section-3/article-93/3 3.chapter-vii/section-3/article-93/4 4.chapter-vii/section-3/article-93/5 5.chapter-vii/section-3/article-93/6 6.chapter-vii/section-3/article-93/7 7.chapter-vii/section-3/article-93/8 8.chapter-vii/section-3/article-93/9 9.chapter-vii/section-3/article-93/10 10.chapter-vii/section-3/article-93/11 11.chapter-vii/section-3/article-94 Article 94chapter-vii/section-3/article-95 Article 95chapter-vii/section-3/article-95/1 1.chapter-vii/section-3/article-95/2 2.chapter-vii/section-3/article-95/3 3.chapter-vii/section-3/article-95/4 4.chapter-vii/section-3/article-95/5 5.chapter-vii/section-3/article-95/6 6.chapter-vii/section-3/article-95/7 7.chapter-vii/section-3/article-96 Article 96chapter-vii/section-3/article-96/1 1.chapter-vii/section-3/article-96/2 2.chapter-vii/section-3/article-96/3 3.chapter-vii/section-3/article-97 Article 97chapter-vii/section-3/article-97/1 1.chapter-vii/section-3/article-97/2 2.chapter-vii/section-3/article-97/3 3.chapter-vii/section-3/article-98 Article 98chapter-vii/section-3/article-98/1 1.chapter-vii/section-3/article-98/2 2.chapter-vii/section-3/article-98/3 3.chapter-vii/section-3/article-98/4 4.chapter-vii/section-3/article-99 Article 99chapter-vii/section-3/article-99/1 1.chapter-vii/section-3/article-99/2 2.chapter-vii/section-3/article-99/3 3.chapter-vii/section-3/article-99/4 4.chapter-vii/section-3/article-100 Article 100chapter-vii/section-3/article-100/1 1.chapter-vii/section-3/article-100/2 2.chapter-vii/section-3/article-100/3 3.chapter-viii CHAPTER VIIIchapter-viii/article-101 Article 101chapter-viii/article-102 Article 102chapter-viii/article-102/1 1.chapter-viii/article-102/2 2.chapter-viii/article-103 Article 103chapter-viii/article-103/1 1.chapter-viii/article-103/2 2.chapter-viii/article-103/3 3.chapter-viii/article-103/4 4.chapter-viii/article-103/5 5.chapter-viii/article-103/6 6.chapter-viii/article-103/7 7.chapter-viii/article-103/8 8.chapter-viii/article-103/9 9.chapter-viii/article-104 Article 104chapter-viii/article-105 Article 105chapter-viii/article-106 Article 106chapter-viii/article-106/1 1.chapter-viii/article-106/2 2.chapter-viii/article-106/3 3.chapter-viii/article-106/4 4.chapter-viii/article-106/5 5.chapter-viii/article-106/6 6.chapter-viii/article-106/7 7.chapter-viii/article-106/8 8.chapter-viii/article-106/9 9.chapter-viii/article-106/10 10.chapter-viii/article-106/11 11.chapter-viii/article-106/12 12.chapter-viii/article-106/13 13.chapter-viii/article-106/14 14.chapter-viii/article-106/15 15.chapter-viii/article-107 Article 107chapter-viii/article-107/1 1.chapter-viii/article-107/2 2.chapter-viii/article-108 Article 108chapter-ix CHAPTER IXchapter-ix/article-109 Article 109chapter-ix/article-109/1 1.chapter-ix/article-109/2 2.chapter-ix/article-109/3 3.chapter-ix/article-109/4 4.chapter-ix/article-110 Article 110chapter-ix/article-110/1 1.chapter-ix/article-110/2 2.chapter-ix/article-111 Article 111chapter-ix/article-111/1 1.chapter-ix/article-111/2 2.chapter-ix/article-112 Article 112chapter-ix/article-113 Article 113chapter-x CHAPTER Xchapter-x/article-114 Article 114chapter-x/article-114/1 1.chapter-x/article-114/2 2.chapter-x/article-114/3 3.chapter-x/article-114/4 4.chapter-x/article-115 Article 115chapter-x/article-115/1 1.chapter-x/article-115/2 2.chapter-x/article-115/3 3.chapter-x/article-115/4 4.chapter-x/article-115/5 5.chapter-x/article-115/6 6.chapter-x/article-116 Article 116chapter-x/article-117 Article 117chapter-x/article-118 Article 118chapter-x/article-119 Article 119chapter-x/article-120 Article 120chapter-x/article-120/1 1.chapter-x/article-120/2 2.chapter-x/article-120/3 3.chapter-x/article-120/4 4.chapter-x/article-120/5 5.chapter-x/article-120/6 6.chapter-x/article-120/7 7.chapter-x/article-120/8 8.chapter-x/article-120/9 9.chapter-x/article-120/10 10.chapter-x/article-120/11 11.chapter-x/article-120/12 12.chapter-x/article-121 Article 121chapter-x/article-122 Article 122chapter-x/article-123 Article 123chapter-x/article-123/1 1.chapter-x/article-123/2 2.chapter-x/article-123/3 3.annex-i ANNEX Iannex-i/chapter-i CHAPTER Iannex-i/chapter-i/1 1.annex-i/chapter-i/2 2.annex-i/chapter-i/3 3.annex-i/chapter-i/4 4.annex-i/chapter-i/5 5.annex-i/chapter-i/6 6.annex-i/chapter-i/7 7.annex-i/chapter-i/8 8.annex-i/chapter-i/9 9.annex-i/chapter-ii CHAPTER IIannex-i/chapter-iii CHAPTER IIIannex-ii ANNEX IIannex-ii/1 1.annex-ii/1.1 1.1.annex-ii/1.2 1.2.annex-ii/2 2.annex-ii/3 3.annex-ii/4 4.annex-ii/5 5.annex-ii/6 6.annex-ii/6.1 6.1.annex-ii/6.2 6.2.annex-iii ANNEX IIIannex-iv ANNEX IVannex-iv/1 1.annex-iv/2 2.annex-iv/3 3.annex-iv/4 4.annex-iv/5 5.annex-iv/6 6.annex-iv/7 7.annex-iv/8 8.annex-iv/9 9.annex-iv/10 10.annex-v ANNEX Vannex-v/1 1.annex-v/2 2.annex-v/3 3.annex-vi ANNEX VIannex-vi/part-a PART Aannex-vi/part-a/1 1.annex-vi/part-a/2 2.annex-vi/part-a/2.1 2.1.annex-vi/part-b PART Bannex-vi/part-c PART Cannex-vi/part-c/1 1.annex-vi/part-c/2 2.annex-vi/part-c/2.1 2.1.annex-vi/part-c/2.2 2.2.annex-vi/part-c/2.3 2.3.annex-vi/part-c/2.4 2.4.annex-vi/part-c/3 3.annex-vi/part-c/3.1 3.1.annex-vi/part-c/3.2 3.2.annex-vi/part-c/3.3 3.3.annex-vi/part-c/3.4 3.4.annex-vi/part-c/3.5 3.5.annex-vi/part-c/3.6 3.6.annex-vi/part-c/3.7 3.7.annex-vi/part-c/3.8 3.8.annex-vi/part-c/3.9 3.9.annex-vi/part-c/3.10 3.10.annex-vi/part-c/4 4.annex-vi/part-c/4.1 4.1.annex-vi/part-c/4.2 4.2.annex-vi/part-c/4.3 4.3.annex-vi/part-c/4.4 4.4.annex-vi/part-c/4.5 4.5.annex-vi/part-c/4.6 4.6.annex-vi/part-c/4.7 4.7.annex-vi/part-c/4.8 4.8.annex-vi/part-c/4.9 4.9.annex-vi/part-c/4.10 4.10.annex-vi/part-c/4.11 4.11.annex-vi/part-c/4.12 4.12.annex-vi/part-c/4.13 4.13.annex-vi/part-c/4.14 4.14.annex-vi/part-c/4.15 4.15.annex-vi/part-c/5 5.annex-vi/part-c/5.1 5.1.annex-vi/part-c/5.2 5.2.annex-vi/part-c/5.3 5.3.annex-vi/part-c/5.4 5.4.annex-vi/part-c/5.5 5.5.annex-vi/part-c/5.6 5.6.annex-vi/part-c/5.7 5.7.annex-vi/part-c/5.8 5.8.annex-vi/part-c/5.9 5.9.annex-vi/part-c/5.10 5.10.annex-vi/part-c/5.11 5.11.annex-vi/part-c/6 6.annex-vi/part-c/6.1 6.1.annex-vi/part-c/6.1.1 6.1.1.annex-vi/part-c/6.1.2 6.1.2.annex-vi/part-c/6.1.3 6.1.3.annex-vi/part-c/6.2 6.2.annex-vi/part-c/6.2.1 6.2.1.annex-vi/part-c/6.2.2 6.2.2.annex-vi/part-c/6.3 6.3.annex-vi/part-c/6.3.1 6.3.1.annex-vi/part-c/6.3.2 6.3.2.annex-vi/part-c/6.3.3 6.3.3.annex-vi/part-c/6.4 6.4.annex-vi/part-c/6.4.1 6.4.1.annex-vi/part-c/6.4.2 6.4.2.annex-vi/part-c/6.4.3 6.4.3.annex-vi/part-c/6.4.4 6.4.4.annex-vi/part-c/6.4.5 6.4.5.annex-vi/part-c/6.5 6.5.annex-vi/part-c/6.5.1 6.5.1.annex-vi/part-c/6.5.2 6.5.2.annex-vi/part-c/6.5.3 6.5.3.annex-vi/part-c/6.5.4 6.5.4.annex-vii ANNEX VIIannex-vii/1 1.annex-vii/1.1 1.1.annex-vii/1.1.1 1.1.1.annex-vii/1.1.2 1.1.2.annex-vii/1.1.3 1.1.3.annex-vii/1.1.4 1.1.4.annex-vii/1.1.5 1.1.5.annex-vii/1.1.6 1.1.6.annex-vii/1.2 1.2.annex-vii/1.2.1 1.2.1.annex-vii/1.2.2 1.2.2.annex-vii/1.2.3 1.2.3.annex-vii/1.2.4 1.2.4.annex-vii/1.2.5 1.2.5.annex-vii/1.2.6 1.2.6.annex-vii/1.2.7 1.2.7.annex-vii/1.2.8 1.2.8.annex-vii/1.2.9 1.2.9.annex-vii/1.3 1.3.annex-vii/1.3.1 1.3.1.annex-vii/1.3.2 1.3.2.annex-vii/1.4 1.4.annex-vii/1.4.1 1.4.1.annex-vii/1.4.2 1.4.2.annex-vii/1.5 1.5.annex-vii/1.6 1.6.annex-vii/1.6.1 1.6.1.annex-vii/1.6.2 1.6.2.annex-vii/2 2.annex-vii/2.1 2.1.annex-vii/2.2 2.2.annex-vii/2.3 2.3.annex-vii/2.4 2.4.annex-vii/3 3.annex-vii/3.1 3.1.annex-vii/3.1.1 3.1.1.annex-vii/3.1.2 3.1.2.annex-vii/3.1.3 3.1.3.annex-vii/3.2 3.2.annex-vii/3.2.1 3.2.1.annex-vii/3.2.2 3.2.2.annex-vii/3.2.3 3.2.3.annex-vii/3.2.4 3.2.4.annex-vii/3.2.5 3.2.5.annex-vii/3.2.6 3.2.6.annex-vii/3.2.7 3.2.7.annex-vii/3.3 3.3.annex-vii/3.3.1 3.3.1.annex-vii/3.3.2 3.3.2.annex-vii/3.4 3.4.annex-vii/3.4.1 3.4.1.annex-vii/3.4.2 3.4.2.annex-vii/3.4.3 3.4.3.annex-vii/3.5 3.5.annex-vii/3.5.1 3.5.1.annex-vii/3.5.2 3.5.2.annex-vii/4 4.annex-vii/4.1 4.1.annex-vii/4.2 4.2.annex-vii/4.3 4.3.annex-vii/4.4 4.4.annex-vii/4.5 4.5.annex-vii/4.5.1 4.5.1.annex-vii/4.5.2 4.5.2.annex-vii/4.5.3 4.5.3.annex-vii/4.5.4 4.5.4.annex-vii/4.5.5 4.5.5.annex-vii/4.5.6 4.5.6.annex-vii/4.6 4.6.annex-vii/4.7 4.7.annex-vii/4.8 4.8.annex-vii/4.9 4.9.annex-vii/4.10 4.10.annex-vii/4.11 4.11.annex-viii ANNEX VIIIannex-viii/chapter-i CHAPTER Iannex-viii/chapter-i/1 1.annex-viii/chapter-i/2 2.annex-viii/chapter-ii CHAPTER IIannex-viii/chapter-iii CHAPTER IIIannex-ix ANNEX IXannex-ix/chapter-i CHAPTER Iannex-ix/chapter-i/1 1.annex-ix/chapter-i/2 2.annex-ix/chapter-i/2.1 2.1.annex-ix/chapter-i/2.2 2.2.annex-ix/chapter-i/2.3 2.3.annex-ix/chapter-i/2.4 2.4.annex-ix/chapter-i/3 3.annex-ix/chapter-i/3.1 3.1.annex-ix/chapter-i/3.2 3.2.annex-ix/chapter-i/3.3 3.3.annex-ix/chapter-i/3.4 3.4.annex-ix/chapter-i/3.5 3.5.annex-ix/chapter-i/3.6 3.6.annex-ix/chapter-i/3.7 3.7.annex-ix/chapter-ii CHAPTER IIannex-ix/chapter-iii CHAPTER IIIannex-x ANNEX Xannex-x/1 1.annex-x/2 2.annex-x/3 3.annex-x/4 4.annex-x/5 5.annex-x/5.1 5.1.annex-x/5.2 5.2.annex-x/5.3 5.3.annex-x/6 6.annex-x/7 7.annex-xi ANNEX XIannex-xi/1 1.annex-xi/2 2.annex-xi/3 3.annex-xi/part-a PART Aannex-xi/part-b PART Bannex-xii ANNEX XIIannex-xii/chapter-i CHAPTER Iannex-xii/chapter-i/1 1.annex-xii/chapter-i/2 2.annex-xii/chapter-i/3 3.annex-xii/chapter-i/4 4.annex-xii/chapter-i/5 5.annex-xii/chapter-i/6 6.annex-xii/chapter-i/7 7.annex-xii/chapter-i/8 8.annex-xii/chapter-ii CHAPTER IIannex-xiii ANNEX XIIIannex-xiii/1 1.annex-xiii/2 2.annex-xiii/3 3.annex-xiii/4 4.annex-xiii/5 5.annex-xiv ANNEX XIVannex-xiv/part-a PART Aannex-xiv/part-a/1 1.annex-xiv/part-a/2 2.annex-xiv/part-a/3 3.annex-xiv/part-a/4 4.annex-xiv/part-b PART Bannex-xv ANNEX XVannex-xv/chapter-i CHAPTER Iannex-xv/chapter-i/1 1.annex-xv/chapter-i/2 2.annex-xv/chapter-i/2.1 2.1.annex-xv/chapter-i/2.2 2.2.annex-xv/chapter-i/2.3 2.3.annex-xv/chapter-i/2.4 2.4.annex-xv/chapter-i/2.5 2.5.annex-xv/chapter-i/2.6 2.6.annex-xv/chapter-i/2.7 2.7.annex-xv/chapter-i/2.8 2.8.annex-xv/chapter-ii CHAPTER IIannex-xv/chapter-ii/1 1.annex-xv/chapter-ii/2 2.annex-xv/chapter-ii/2.1 2.1.annex-xv/chapter-ii/2.2 2.2.annex-xv/chapter-ii/2.3 2.3.annex-xv/chapter-ii/2.4 2.4.annex-xv/chapter-ii/2.5 2.5.annex-xv/chapter-ii/2.6 2.6.annex-xv/chapter-ii/2.7 2.7.annex-xv/chapter-ii/2.8 2.8.annex-xv/chapter-ii/3 3.annex-xv/chapter-ii/3.1 3.1.annex-xv/chapter-ii/3.1.1 3.1.1.annex-xv/chapter-ii/3.1.2 3.1.2.annex-xv/chapter-ii/3.1.3 3.1.3.annex-xv/chapter-ii/3.1.4 3.1.4.annex-xv/chapter-ii/3.1.5 3.1.5.annex-xv/chapter-ii/3.2 3.2.annex-xv/chapter-ii/3.3 3.3.annex-xv/chapter-ii/3.4 3.4.annex-xv/chapter-ii/3.5 3.5.annex-xv/chapter-ii/3.6 3.6.annex-xv/chapter-ii/3.6.1 3.6.1.annex-xv/chapter-ii/3.6.2 3.6.2.annex-xv/chapter-ii/3.6.3 3.6.3.annex-xv/chapter-ii/3.6.4 3.6.4.annex-xv/chapter-ii/3.6.5 3.6.5.annex-xv/chapter-ii/3.6.6 3.6.6.annex-xv/chapter-ii/3.7 3.7.annex-xv/chapter-ii/3.8 3.8.annex-xv/chapter-ii/3.9 3.9.annex-xv/chapter-ii/3.10 3.10.annex-xv/chapter-ii/3.11 3.11.annex-xv/chapter-ii/3.12 3.12.annex-xv/chapter-ii/3.13 3.13.annex-xv/chapter-ii/3.14 3.14.annex-xv/chapter-ii/3.15 3.15.annex-xv/chapter-ii/3.16 3.16.annex-xv/chapter-ii/3.17 3.17.annex-xv/chapter-ii/3.18 3.18.annex-xv/chapter-ii/3.19 3.19.annex-xv/chapter-ii/4 4.annex-xv/chapter-ii/4.1 4.1.annex-xv/chapter-ii/4.2 4.2.annex-xv/chapter-ii/4.3 4.3.annex-xv/chapter-ii/4.4 4.4.annex-xv/chapter-ii/4.5 4.5.annex-xv/chapter-ii/4.6 4.6.annex-xv/chapter-iii CHAPTER IIIannex-xv/chapter-iii/1 1.annex-xv/chapter-iii/2 2.annex-xv/chapter-iii/3 3.annex-xv/chapter-iii/4 4.annex-xv/chapter-iii/5 5.annex-xv/chapter-iii/6 6.annex-xv/chapter-iii/7 7.annex-xvi ANNEX XVIannex-xvi/1 1.annex-xvi/2 2.annex-xvi/3 3.annex-xvi/4 4.annex-xvi/5 5.annex-xvi/6 6.annex-xvii ANNEX XVIIDefinitions: served for the current text of an entry only.
Sentences printing a listed verb: 1728 read in this text, 141 quoted and 1587 withheld.
chapter-i/article-1/2 The necessary common specifications shall be adopted by 26 May 2020.chapter-i/article-1/13 This Regulation shall not affect the application of Directive 2013/59/Euratom.chapter-ii/article-5/5 This paragraph shall not apply to devices that are manufactured on an industrial scale.chapter-ii/article-10/4 The technical documentation shall include the elements set out in Annexes II and III.chapter-ii/article-13/4 Importers shall add their details to the registration in accordance with Article 31.chapter-ii/article-17/3 The Commission shall keep the information publicly available.chapter-ii/article-17/9 The Commission shall make such information publicly available.chapter-ii/article-19/1 The manufacturer shall continuously update the EU declaration of conformity.chapter-ii/article-20/4 The CE marking shall be affixed before the device is placed on the market.chapter-ii/article-22/5 Where those periods differ, the longest period shall apply.chapter-ii/article-23/1 Supporting evidence shall be kept available for the competent authorities of the Member States.chapter-iii/article-27/4 Higher levels of packaging shall not be understood to include shipping containers.chapter-iii/article-30/3 Importers shall add their details to the relevant entry/entries.chapter-iii/article-32/1 After its validation, the notified body shall upload the summary to Eudamed.chapter-iii/article-33/4 The Commission shall provide for technical and administrative support to users of Eudamed.chapter-iv/article-36/1 In particular, notified bodies shall comply with Annex VII.chapter-iv/article-37/3 Notified bodies shall make publicly available a list of their subsidiaries.chapter-iv/article-39/1 Once the application is complete that authority shall send it to the Commission.chapter-iv/article-42/11 The designation shall become valid the day after the notification is published in NANDO.chapter-iv/article-43/2 The Commission shall ensure that the list is kept up to date.chapter-iv/article-45/3 Such reviews shall be conducted utilising CS.chapter-iv/article-45/4 The reviews shall be conducted utilising appropriate expertise.chapter-iv/article-46/2 The Commission shall immediately publish the amended notification in NANDO.chapter-iv/article-47/3 The reporting and outcome of that assessment shall follow the principles of Article 39.chapter-iv/article-49 This group shall meet on a regular basis and at least annually.chapter-iv/article-49 The bodies notified under this Regulation shall participate in the work of that group.chapter-v/section-1/article-51/1 Classification shall be carried out in accordance with Annex VIII.chapter-v/section-1/article-51/2 The decision shall be made available upon request.chapter-v/section-2/article-54/3 That notification shall be accompanied by the clinical evaluation assessment report.chapter-v/section-2/article-56/1 The minimum content of the certificates shall be as set out in Annex XII.chapter-v/section-2/article-56/4 The notified body shall give the reasons for its decision.chapter-v/section-2/article-56/5 Such information shall be accessible to the public.chapter-vi/article-61/2 The manufacturer shall give due consideration to the views expressed by the expert panel.chapter-vi/article-62/3 Clinical investigations shall be subject to scientific and ethical review.chapter-vi/article-63/2 In that case, the witness shall sign and date the informed consent document.chapter-vi/article-63/2 The informed consent shall be documented.chapter-vi/article-64/2 The subject shall as far as possible take part in the informed consent procedure.chapter-vi/article-73/4 No personal data of subjects shall be publicly available.chapter-vi/article-75/1 Changes to the relevant documentation shall be clearly identifiable.chapter-vi/article-76/2 That opinion shall be delivered within seven days.chapter-vi/article-78/10 That Member State shall provide for an appeal procedure in respect of such refusal.chapter-vi/article-78/14 After 27 May 2027, all Member States shall be required to apply that procedure.chapter-vi/article-80/2 The period for reporting shall take account of the severity of the event.chapter-vii/section-1/article-83/3 The technical documentation shall be updated accordingly.chapter-vii/section-2/article-89/4 The competent authority shall monitor the manufacturer's investigation of a serious incident.chapter-vii/section-2/article-92/1 That electronic system shall include relevant links to the UDI database.chapter-vii/section-3/article-93/6 The report shall set out any corrective actions needed.chapter-vii/section-3/article-93/8 The Member States shall review and assess the functioning of their market surveillance activities.chapter-vii/section-3/article-94 The relevant economic operators shall cooperate with the competent authorities.chapter-vii/section-3/article-99/1 Where the measure is of general applicability, it shall be appropriately published.chapter-viii/article-103/2 They shall represent the competent authorities of the Member States.chapter-viii/article-103/2 The names and affiliation of members shall be made public by the Commission.chapter-viii/article-103/2 The alternates shall represent and vote for the members in their absence.chapter-viii/article-103/4 The MDCG shall use its best endeavours to reach consensus.chapter-viii/article-103/5 The MDCG shall be chaired by a representative of the Commission.chapter-viii/article-103/5 The chair shall not take part in votes of the MDCG.chapter-viii/article-103/7 The MDCG may establish standing or temporary sub-groups.chapter-viii/article-106/2 Expert panels and expert laboratories may be appointed on a standing or temporary basis.chapter-viii/article-106/3 The members of expert panels shall perform their tasks with impartiality and objectivity.chapter-viii/article-106/3 They shall neither seek nor take instructions from notified bodies or manufacturers.chapter-viii/article-106/6 That list shall be published on the Commission website.chapter-viii/article-107/1 They shall undertake to act in the public interest and in an independent manner.chapter-viii/article-107/1 The declaration of interests shall be made publicly available on the Commission website.chapter-ix/article-111/2 The structure and level of fees shall be made publicly available on request.chapter-ix/article-113 The penalties provided for shall be effective, proportionate, and dissuasive.chapter-x/article-114/1 The Commission shall be assisted by a Committee on Medical Devices.chapter-x/article-114/1 That Committee shall be a committee within the meaning of Regulation (EU) No 182/2011.chapter-x/article-115/3 It shall not affect the validity of any delegated acts already in force.chapter-x/article-120/2 They shall however become void at the latest on 27 May 2024.chapter-x/article-123/2 It shall apply from 26 May 2020.annex-i/chapter-i/3 Manufacturers shall establish, implement, document and maintain a risk management system.annex-i/chapter-i/4 Manufacturers shall inform users of any residual risks.annex-i/chapter-ii Special attention shall be given to nanomaterials.annex-i/chapter-ii Where necessary devices shall be designed to facilitate their safe cleaning, disinfection, and/or re-sterilisation.annex-i/chapter-ii Such procedures shall be described in the instructions for use.annex-i/chapter-ii The limits of accuracy shall be indicated by the manufacturer.annex-i/chapter-ii The function of the controls and indicators shall be clearly specified on the devices.annex-i/chapter-iii Any symbol or identification colour used shall conform to the harmonised standards or CS.annex-v/1 The CE marking shall consist of the initials ‘CE’ taking the following form:annex-v/3 This minimum dimension may be waived for small-scale devices.annex-vi/part-c/1 Those individual components may be devices in themselves.annex-vi/part-c/1 The combination of items may be modified, adjusted or customized to meet specific needs.annex-vi/part-c/2.2 The manufacturer shall assign and maintain unique UDIs for its devices.annex-vi/part-c/2.3 Only the manufacturer may place the UDI on the device or its packaging.annex-vi/part-c/3.1 A UDI shall be assigned to the device itself or its packaging.annex-vi/part-c/3.1 Higher levels of packaging shall have their own UDI.annex-vi/part-c/3.2 Shipping containers shall be exempted from the requirement in Section 3.1.annex-vi/part-c/3.3 The UDI shall contain two parts: a UDI-DI and a UDI-PI.annex-vi/part-c/3.4 The UDI-DI shall be unique at each level of device packaging.annex-vi/part-c/3.8 The manufacturer shall assign the UDI to a device following the relevant coding standard.annex-vi/part-c/4.6 All parts and elements of the linear bar code shall be distinguishable and identifiable.annex-vi/part-c/4.8 The HRI format shall follow the rules of the UDI code-issuing entity.annex-vi/part-c/4.10 Devices that are reusable shall bear a UDI carrier on the device itself.annex-vi/part-c/5.3 Appropriate methods/procedures for validation of the data provided shall be implemented.annex-vi/part-c/5.10 The use of free-text fields shall, however, be minimized in order to reduce translations.annex-vi/part-c/6.1.3 The UDI of the implantable device shall be identifiable prior to implantation.annex-vi/part-c/6.4.3 A configurable device UDI-PI shall be assigned to each individual configurable device.annex-vi/part-c/6.5.3 Minor software revisions shall require a new UDI-PI and not a new UDI-DI.annex-vi/part-c/6.5.3 Minor software revisions shall be identified by a manufacturer-specific form of identification.annex-vii/1.1.1 Its legal personality and status shall be fully documented.annex-vii/1.2.2 The investigation, outcome and its resolution shall be documented.annex-vii/1.2.5 Notified bodies shall make publicly available the declarations of interest of their top-level management.annex-vii/1.3.2 Proprietary rights shall be protected.annex-vii/1.6.2 The notified body shall take into consideration guidance and best practice documents.annex-vii/4.3 It shall be kept by the notified body.annex-vii/4.3 The outcome of each review of an application shall be documented.annex-vii/4.10 The results of the evaluation and any decisions taken shall be thoroughly documented.annex-ix/chapter-i/2.2 Implementation of the quality management system shall ensure compliance with this Regulation.annex-ix/chapter-i/2.3 The notified body in question shall document its rationale for the samples taken.annex-ix/chapter-i/2.3 The notified body shall notify the manufacturer of its decision to issue the certificate.annex-ix/chapter-i/2.3 The decision shall contain the conclusions of the audit and a reasoned report.annex-ix/chapter-ii The application shall describe the design, manufacture and performance of the device in question.annex-ix/chapter-ii It shall include the technical documentation as referred to in Annexes II and III.annex-ix/chapter-ii The notified body shall not deliver the certificate if that scientific opinion is unfavourable.annex-x/2 Application The manufacturer shall lodge an application for assessment with a notified body.annex-x/4 The certificate shall be drawn up in accordance with Annex XII.annex-x/7 Section 8 of Annex IX shall apply.annex-xi/part-a The first and second paragraph of Section 2.3 of Annex IX shall apply.annex-xi/part-a The notified body shall notify the manufacturer of its decision to issue the certificate.annex-xi/part-a Section 2.4 of Annex IX shall apply.annex-xi/part-a Section 8 of Annex IX shall apply.annex-xi/part-a Section 8 of Annex IX shall apply.annex-xi/part-b Section 8 of Annex IX shall apply.annex-xi/part-b Section 8 of Annex IX shall apply.annex-xii/chapter-i/1 Certificates shall be drawn up in one of the official languages of the Union.annex-xii/chapter-i/2 Each certificate shall refer to only one conformity assessment procedure.annex-xii/chapter-i/3 Certificates shall only be issued to one manufacturer.annex-xiii/4 In the case of implantable devices, the period shall be at least 15 years.annex-xiii/4 Section 8 of Annex IX shall apply.annex-xiv/part-a/3 Considerations of equivalence shall be based on proper scientific justification.annex-xv/chapter-i/2.6 The endpoints shall be determined and assessed using scientifically valid methodologies.annex-xv/chapter-i/2.6 The primary endpoint shall be appropriate to the device and clinically relevant.annex-xv/chapter-i/2.7 Investigators shall have access to the technical and clinical data regarding the device.annex-xv/chapter-ii/2 The IB shall be clearly identified and contain in particular the following information:annex-xv/chapter-ii/3 It shall contain in particular the information as laid down in this Annex.annex-xv/chapter-ii/3.15 Such procedures shall for implantable devices, cover as a minimum traceability.annex-xv/chapter-iii/3 In the case of implantable devices, the period shall be at least 15 years.annex-xv/chapter-iii/5 The Sponsor shall complete the follow-up of investigation subjects.chapter-i/article-1/2 4 withheld: over the quote capchapter-i/article-1/3 1 withheld: over the quote capchapter-i/article-1/4 1 withheld: over the quote capchapter-i/article-1/6 1 withheld: over the quote capchapter-i/article-1/7 2 withheld: over the quote capchapter-i/article-1/8 3 withheld: over the quote capchapter-i/article-1/9 3 withheld: over the quote capchapter-i/article-1/10 4 withheld: over the quote capchapter-i/article-1/12 1 withheld: over the quote capchapter-i/article-1/14 1 withheld: over the quote capchapter-i/article-1/15 1 withheld: over the quote capchapter-i/article-1/16 1 withheld: over the quote capchapter-i/article-2 7 withheld: over the quote capchapter-i/article-4/1 2 withheld: over the quote capchapter-i/article-4/2 2 withheld: over the quote capchapter-i/article-4/3 1 withheld: over the quote capchapter-i/article-4/4 1 withheld: over the quote capchapter-ii/article-5/1 1 withheld: over the quote capchapter-ii/article-5/2 1 withheld: over the quote capchapter-ii/article-5/3 1 withheld: over the quote capchapter-ii/article-5/4 1 withheld: over the quote capchapter-ii/article-5/5 3 withheld: over the quote capchapter-ii/article-5/6 2 withheld: over the quote capchapter-ii/article-6/1 1 withheld: over the quote capchapter-ii/article-6/2 1 withheld: over the quote capchapter-ii/article-6/3 1 withheld: over the quote capchapter-ii/article-6/4 1 withheld: over the quote capchapter-ii/article-7 1 withheld: over the quote capchapter-ii/article-8/1 3 withheld: over the quote capchapter-ii/article-8/2 1 withheld: over the quote capchapter-ii/article-9/1 2 withheld: over the quote capchapter-ii/article-9/2 1 withheld: over the quote capchapter-ii/article-9/3 1 withheld: over the quote capchapter-ii/article-9/4 1 withheld: over the quote capchapter-ii/article-10/1 1 withheld: over the 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withheld: over the quote capchapter-ii/article-14/5 2 withheld: over the quote capchapter-ii/article-14/6 4 withheld: over the quote capchapter-ii/article-15/1 3 withheld: over the quote capchapter-ii/article-15/2 1 withheld: over the quote capchapter-ii/article-15/3 1 withheld: over the quote capchapter-ii/article-15/4 1 withheld: over the quote capchapter-ii/article-15/5 1 withheld: over the quote capchapter-ii/article-15/6 2 withheld: over the quote capchapter-ii/article-16/1 2 withheld: over the quote capchapter-ii/article-16/2 2 withheld: over the quote capchapter-ii/article-16/3 3 withheld: over the quote capchapter-ii/article-16/4 2 withheld: over the quote capchapter-ii/article-17/1 1 withheld: over the quote capchapter-ii/article-17/2 2 withheld: over the quote capchapter-ii/article-17/3 3 withheld: over the quote capchapter-ii/article-17/4 1 withheld: over the quote capchapter-ii/article-17/5 4 withheld: over the quote capchapter-ii/article-17/6 1 withheld: over the quote 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capannex-xv/chapter-ii/4.2 1 withheld: over the quote capannex-xv/chapter-ii/4.6 1 withheld: over the quote capannex-xv/chapter-iii/1 2 withheld: over the quote capannex-xv/chapter-iii/2 1 withheld: over the quote capannex-xv/chapter-iii/3 2 withheld: over the quote capannex-xv/chapter-iii/4 1 withheld: over the quote capannex-xv/chapter-iii/6 1 withheld: over the quote capannex-xv/chapter-iii/7 1 withheld: over the quote capfab624c8e1dc (current text), first observed 2026-08-12Clause anchors: read; 1000 placed and 0 withheld.
chapter-i CHAPTER Ichapter-i/article-1 Article 1chapter-i/article-1/1 1.chapter-i/article-1/2 2.chapter-i/article-1/3 3.chapter-i/article-1/4 4.chapter-i/article-1/5 5.chapter-i/article-1/6 6.chapter-i/article-1/7 7.chapter-i/article-1/8 8.chapter-i/article-1/9 9.chapter-i/article-1/10 10.chapter-i/article-1/11 11.chapter-i/article-1/12 12.chapter-i/article-1/13 13.chapter-i/article-1/14 14.chapter-i/article-1/15 15.chapter-i/article-1/16 16.chapter-i/article-2 Article 2chapter-i/article-3 Article 3chapter-i/article-4 Article 4chapter-i/article-4/1 1.chapter-i/article-4/2 2.chapter-i/article-4/3 3.chapter-i/article-4/4 4.chapter-ii CHAPTER IIchapter-ii/article-5 Article 5chapter-ii/article-5/1 1.chapter-ii/article-5/2 2.chapter-ii/article-5/3 3.chapter-ii/article-5/4 4.chapter-ii/article-5/5 5.chapter-ii/article-5/6 6.chapter-ii/article-6 Article 6chapter-ii/article-6/1 1.chapter-ii/article-6/2 2.chapter-ii/article-6/3 3.chapter-ii/article-6/4 4.chapter-ii/article-7 Article 7chapter-ii/article-8 Article 8chapter-ii/article-8/1 1.chapter-ii/article-8/2 2.chapter-ii/article-9 Article 9chapter-ii/article-9/1 1.chapter-ii/article-9/2 2.chapter-ii/article-9/3 3.chapter-ii/article-9/4 4.chapter-ii/article-10 Article 10chapter-ii/article-10/1 1.chapter-ii/article-10/2 2.chapter-ii/article-10/3 3.chapter-ii/article-10/4 4.chapter-ii/article-10/5 5.chapter-ii/article-10/6 6.chapter-ii/article-10/7 7.chapter-ii/article-10/8 8.chapter-ii/article-10/9 9.chapter-ii/article-10/10 10.chapter-ii/article-10/11 11.chapter-ii/article-10/12 12.chapter-ii/article-10/13 13.chapter-ii/article-10/14 14.chapter-ii/article-10/15 15.chapter-ii/article-10/16 16.chapter-ii/article-11 Article 11chapter-ii/article-11/1 1.chapter-ii/article-11/2 2.chapter-ii/article-11/3 3.chapter-ii/article-11/4 4.chapter-ii/article-11/5 5.chapter-ii/article-11/6 6.chapter-ii/article-11/7 7.chapter-ii/article-12 Article 12chapter-ii/article-13 Article 13chapter-ii/article-13/1 1.chapter-ii/article-13/2 2.chapter-ii/article-13/3 3.chapter-ii/article-13/4 4.chapter-ii/article-13/5 5.chapter-ii/article-13/6 6.chapter-ii/article-13/7 7.chapter-ii/article-13/8 8.chapter-ii/article-13/9 9.chapter-ii/article-13/10 10.chapter-ii/article-14 Article 14chapter-ii/article-14/1 1.chapter-ii/article-14/2 2.chapter-ii/article-14/3 3.chapter-ii/article-14/4 4.chapter-ii/article-14/5 5.chapter-ii/article-14/6 6.chapter-ii/article-15 Article 15chapter-ii/article-15/1 1.chapter-ii/article-15/2 2.chapter-ii/article-15/3 3.chapter-ii/article-15/4 4.chapter-ii/article-15/5 5.chapter-ii/article-15/6 6.chapter-ii/article-16 Article 16chapter-ii/article-16/1 1.chapter-ii/article-16/2 2.chapter-ii/article-16/3 3.chapter-ii/article-16/4 4.chapter-ii/article-17 Article 17chapter-ii/article-17/1 1.chapter-ii/article-17/2 2.chapter-ii/article-17/3 3.chapter-ii/article-17/4 4.chapter-ii/article-17/5 5.chapter-ii/article-17/6 6.chapter-ii/article-17/7 7.chapter-ii/article-17/8 8.chapter-ii/article-17/9 9.chapter-ii/article-17/10 10.chapter-ii/article-18 Article 18chapter-ii/article-18/1 1.chapter-ii/article-18/2 2.chapter-ii/article-18/3 3.chapter-ii/article-19 Article 19chapter-ii/article-19/1 1.chapter-ii/article-19/2 2.chapter-ii/article-19/3 3.chapter-ii/article-19/4 4.chapter-ii/article-20 Article 20chapter-ii/article-20/1 1.chapter-ii/article-20/2 2.chapter-ii/article-20/3 3.chapter-ii/article-20/4 4.chapter-ii/article-20/5 5.chapter-ii/article-20/6 6.chapter-ii/article-21 Article 21chapter-ii/article-21/1 1.chapter-ii/article-21/2 2.chapter-ii/article-21/3 3.chapter-ii/article-22 Article 22chapter-ii/article-22/1 1.chapter-ii/article-22/2 2.chapter-ii/article-22/3 3.chapter-ii/article-22/4 4.chapter-ii/article-22/5 5.chapter-ii/article-23 Article 23chapter-ii/article-23/1 1.chapter-ii/article-23/2 2.chapter-ii/article-24 Article 24chapter-iii CHAPTER IIIchapter-iii/article-25 Article 25chapter-iii/article-25/1 1.chapter-iii/article-25/2 2.chapter-iii/article-26 Article 26chapter-iii/article-27 Article 27chapter-iii/article-27/1 1.chapter-iii/article-27/2 2.chapter-iii/article-27/3 3.chapter-iii/article-27/4 4.chapter-iii/article-27/5 5.chapter-iii/article-27/6 6.chapter-iii/article-27/7 7.chapter-iii/article-27/8 8.chapter-iii/article-27/9 9.chapter-iii/article-27/10 10.chapter-iii/article-27/11 11.chapter-iii/article-27/12 12.chapter-iii/article-28 Article 28chapter-iii/article-28/1 1.chapter-iii/article-28/2 2.chapter-iii/article-28/3 3.chapter-iii/article-28/4 4.chapter-iii/article-29 Article 29chapter-iii/article-29/1 1.chapter-iii/article-29/2 2.chapter-iii/article-29/3 3.chapter-iii/article-29/4 4.chapter-iii/article-30 Article 30chapter-iii/article-30/1 1.chapter-iii/article-30/2 2.chapter-iii/article-30/3 3.chapter-iii/article-31 Article 31chapter-iii/article-31/1 1.chapter-iii/article-31/2 2.chapter-iii/article-31/3 3.chapter-iii/article-31/4 4.chapter-iii/article-31/5 5.chapter-iii/article-31/6 6.chapter-iii/article-31/7 7.chapter-iii/article-31/8 8.chapter-iii/article-32 Article 32chapter-iii/article-32/1 1.chapter-iii/article-32/2 2.chapter-iii/article-32/3 3.chapter-iii/article-33 Article 33chapter-iii/article-33/1 1.chapter-iii/article-33/2 2.chapter-iii/article-33/3 3.chapter-iii/article-33/4 4.chapter-iii/article-33/5 5.chapter-iii/article-33/6 6.chapter-iii/article-33/7 7.chapter-iii/article-33/8 8.chapter-iii/article-33/9 9.chapter-iii/article-34 Article 34chapter-iii/article-34/1 1.chapter-iii/article-34/2 2.chapter-iii/article-34/3 3.chapter-iv CHAPTER IVchapter-iv/article-35 Article 35chapter-iv/article-35/1 1.chapter-iv/article-35/2 2.chapter-iv/article-35/3 3.chapter-iv/article-35/4 4.chapter-iv/article-35/5 5.chapter-iv/article-35/6 6.chapter-iv/article-35/7 7.chapter-iv/article-35/8 8.chapter-iv/article-36 Article 36chapter-iv/article-36/1 1.chapter-iv/article-36/2 2.chapter-iv/article-36/3 3.chapter-iv/article-37 Article 37chapter-iv/article-37/1 1.chapter-iv/article-37/2 2.chapter-iv/article-37/3 3.chapter-iv/article-37/4 4.chapter-iv/article-37/5 5.chapter-iv/article-38 Article 38chapter-iv/article-38/1 1.chapter-iv/article-38/2 2.chapter-iv/article-38/3 3.chapter-iv/article-39 Article 39chapter-iv/article-39/1 1.chapter-iv/article-39/2 2.chapter-iv/article-39/3 3.chapter-iv/article-39/4 4.chapter-iv/article-39/5 5.chapter-iv/article-39/6 6.chapter-iv/article-39/7 7.chapter-iv/article-39/8 8.chapter-iv/article-39/9 9.chapter-iv/article-39/10 10.chapter-iv/article-40 Article 40chapter-iv/article-40/1 1.chapter-iv/article-40/2 2.chapter-iv/article-41 Article 41chapter-iv/article-42 Article 42chapter-iv/article-42/1 1.chapter-iv/article-42/2 2.chapter-iv/article-42/3 3.chapter-iv/article-42/4 4.chapter-iv/article-42/5 5.chapter-iv/article-42/6 6.chapter-iv/article-42/7 7.chapter-iv/article-42/8 8.chapter-iv/article-42/9 9.chapter-iv/article-42/10 10.chapter-iv/article-42/11 11.chapter-iv/article-42/12 12.chapter-iv/article-42/13 13.chapter-iv/article-43 Article 43chapter-iv/article-43/1 1.chapter-iv/article-43/2 2.chapter-iv/article-44 Article 44chapter-iv/article-44/1 1.chapter-iv/article-44/2 2.chapter-iv/article-44/3 3.chapter-iv/article-44/4 4.chapter-iv/article-44/5 5.chapter-iv/article-44/6 6.chapter-iv/article-44/7 7.chapter-iv/article-44/8 8.chapter-iv/article-44/9 9.chapter-iv/article-44/10 10.chapter-iv/article-44/11 11.chapter-iv/article-44/12 12.chapter-iv/article-45 Article 45chapter-iv/article-45/1 1.chapter-iv/article-45/2 2.chapter-iv/article-45/3 3.chapter-iv/article-45/4 4.chapter-iv/article-45/5 5.chapter-iv/article-45/6 6.chapter-iv/article-46 Article 46chapter-iv/article-46/1 1.chapter-iv/article-46/2 2.chapter-iv/article-46/3 3.chapter-iv/article-46/4 4.chapter-iv/article-46/5 5.chapter-iv/article-46/6 6.chapter-iv/article-46/7 7.chapter-iv/article-46/8 8.chapter-iv/article-46/9 9.chapter-iv/article-47 Article 47chapter-iv/article-47/1 1.chapter-iv/article-47/2 2.chapter-iv/article-47/3 3.chapter-iv/article-47/4 4.chapter-iv/article-47/5 5.chapter-iv/article-48 Article 48chapter-iv/article-48/1 1.chapter-iv/article-48/2 2.chapter-iv/article-48/3 3.chapter-iv/article-48/4 4.chapter-iv/article-48/5 5.chapter-iv/article-49 Article 49chapter-iv/article-50 Article 50chapter-v CHAPTER Vchapter-v/section-1 SECTION 1chapter-v/section-1/article-51 Article 51chapter-v/section-1/article-51/1 1.chapter-v/section-1/article-51/2 2.chapter-v/section-1/article-51/3 3.chapter-v/section-1/article-51/4 4.chapter-v/section-1/article-51/5 5.chapter-v/section-1/article-51/6 6.chapter-v/section-2 SECTION 2chapter-v/section-2/article-52 Article 52chapter-v/section-2/article-52/1 1.chapter-v/section-2/article-52/2 2.chapter-v/section-2/article-52/3 3.chapter-v/section-2/article-52/4 4.chapter-v/section-2/article-52/5 5.chapter-v/section-2/article-52/6 6.chapter-v/section-2/article-52/7 7.chapter-v/section-2/article-52/8 8.chapter-v/section-2/article-52/9 9.chapter-v/section-2/article-52/10 10.chapter-v/section-2/article-52/11 11.chapter-v/section-2/article-52/12 12.chapter-v/section-2/article-52/13 13.chapter-v/section-2/article-52/14 14.chapter-v/section-2/article-53 Article 53chapter-v/section-2/article-53/1 1.chapter-v/section-2/article-53/2 2.chapter-v/section-2/article-53/3 3.chapter-v/section-2/article-53/4 4.chapter-v/section-2/article-53/5 5.chapter-v/section-2/article-54 Article 54chapter-v/section-2/article-54/1 1.chapter-v/section-2/article-54/2 2.chapter-v/section-2/article-54/3 3.chapter-v/section-2/article-54/4 4.chapter-v/section-2/article-54/5 5.chapter-v/section-2/article-55 Article 55chapter-v/section-2/article-55/1 1.chapter-v/section-2/article-55/2 2.chapter-v/section-2/article-55/3 3.chapter-v/section-2/article-56 Article 56chapter-v/section-2/article-56/1 1.chapter-v/section-2/article-56/2 2.chapter-v/section-2/article-56/3 3.chapter-v/section-2/article-56/4 4.chapter-v/section-2/article-56/5 5.chapter-v/section-2/article-56/6 6.chapter-v/section-2/article-57 Article 57chapter-v/section-2/article-57/1 1.chapter-v/section-2/article-57/2 2.chapter-v/section-2/article-58 Article 58chapter-v/section-2/article-58/1 1.chapter-v/section-2/article-58/2 2.chapter-v/section-2/article-59 Article 59chapter-v/section-2/article-59/1 1.chapter-v/section-2/article-59/2 2.chapter-v/section-2/article-59/3 3.chapter-v/section-2/article-60 Article 60chapter-v/section-2/article-60/1 1.chapter-v/section-2/article-60/2 2.chapter-vi CHAPTER VIchapter-vi/article-61 Article 61chapter-vi/article-61/1 1.chapter-vi/article-61/2 2.chapter-vi/article-61/3 3.chapter-vi/article-61/4 4.chapter-vi/article-61/5 5.chapter-vi/article-61/6 6.chapter-vi/article-61/7 7.chapter-vi/article-61/8 8.chapter-vi/article-61/9 9.chapter-vi/article-61/10 10.chapter-vi/article-61/11 11.chapter-vi/article-61/12 12.chapter-vi/article-61/13 13.chapter-vi/article-62 Article 62chapter-vi/article-62/1 1.chapter-vi/article-62/2 2.chapter-vi/article-62/3 3.chapter-vi/article-62/4 4.chapter-vi/article-62/5 5.chapter-vi/article-62/6 6.chapter-vi/article-62/7 7.chapter-vi/article-63 Article 63chapter-vi/article-63/1 1.chapter-vi/article-63/2 2.chapter-vi/article-63/3 3.chapter-vi/article-63/4 4.chapter-vi/article-63/5 5.chapter-vi/article-63/6 6.chapter-vi/article-63/7 7.chapter-vi/article-64 Article 64chapter-vi/article-64/1 1.chapter-vi/article-64/2 2.chapter-vi/article-65 Article 65chapter-vi/article-66 Article 66chapter-vi/article-67 Article 67chapter-vi/article-68 Article 68chapter-vi/article-68/1 1.chapter-vi/article-68/2 2.chapter-vi/article-68/3 3.chapter-vi/article-69 Article 69chapter-vi/article-69/1 1.chapter-vi/article-69/2 2.chapter-vi/article-70 Article 70chapter-vi/article-70/1 1.chapter-vi/article-70/2 2.chapter-vi/article-70/3 3.chapter-vi/article-70/4 4.chapter-vi/article-70/5 5.chapter-vi/article-70/6 6.chapter-vi/article-70/7 7.chapter-vi/article-70/8 8.chapter-vi/article-70/9 9.chapter-vi/article-71 Article 71chapter-vi/article-71/1 1.chapter-vi/article-71/2 2.chapter-vi/article-71/3 3.chapter-vi/article-71/4 4.chapter-vi/article-72 Article 72chapter-vi/article-72/1 1.chapter-vi/article-72/2 2.chapter-vi/article-72/3 3.chapter-vi/article-72/4 4.chapter-vi/article-72/5 5.chapter-vi/article-72/6 6.chapter-vi/article-73 Article 73chapter-vi/article-73/1 1.chapter-vi/article-73/2 2.chapter-vi/article-73/3 3.chapter-vi/article-73/4 4.chapter-vi/article-73/5 5.chapter-vi/article-74 Article 74chapter-vi/article-74/1 1.chapter-vi/article-74/2 2.chapter-vi/article-75 Article 75chapter-vi/article-75/1 1.chapter-vi/article-75/2 2.chapter-vi/article-75/3 3.chapter-vi/article-75/4 4.chapter-vi/article-76 Article 76chapter-vi/article-76/1 1.chapter-vi/article-76/2 2.chapter-vi/article-76/3 3.chapter-vi/article-76/4 4.chapter-vi/article-77 Article 77chapter-vi/article-77/1 1.chapter-vi/article-77/2 2.chapter-vi/article-77/3 3.chapter-vi/article-77/4 4.chapter-vi/article-77/5 5.chapter-vi/article-77/6 6.chapter-vi/article-77/7 7.chapter-vi/article-78 Article 78chapter-vi/article-78/1 1.chapter-vi/article-78/2 2.chapter-vi/article-78/3 3.chapter-vi/article-78/4 4.chapter-vi/article-78/5 5.chapter-vi/article-78/6 6.chapter-vi/article-78/7 7.chapter-vi/article-78/8 8.chapter-vi/article-78/9 9.chapter-vi/article-78/10 10.chapter-vi/article-78/11 11.chapter-vi/article-78/12 12.chapter-vi/article-78/13 13.chapter-vi/article-78/14 14.chapter-vi/article-79 Article 79chapter-vi/article-80 Article 80chapter-vi/article-80/1 1.chapter-vi/article-80/2 2.chapter-vi/article-80/3 3.chapter-vi/article-80/4 4.chapter-vi/article-80/5 5.chapter-vi/article-80/6 6.chapter-vi/article-81 Article 81chapter-vi/article-82 Article 82chapter-vi/article-82/1 1.chapter-vi/article-82/2 2.chapter-vii CHAPTER VIIchapter-vii/section-1 SECTION 1chapter-vii/section-1/article-83 Article 83chapter-vii/section-1/article-83/1 1.chapter-vii/section-1/article-83/2 2.chapter-vii/section-1/article-83/3 3.chapter-vii/section-1/article-83/4 4.chapter-vii/section-1/article-84 Article 84chapter-vii/section-1/article-85 Article 85chapter-vii/section-1/article-86 Article 86chapter-vii/section-1/article-86/1 1.chapter-vii/section-1/article-86/2 2.chapter-vii/section-1/article-86/3 3.chapter-vii/section-2 SECTION 2chapter-vii/section-2/article-87 Article 87chapter-vii/section-2/article-87/1 1.chapter-vii/section-2/article-87/2 2.chapter-vii/section-2/article-87/3 3.chapter-vii/section-2/article-87/4 4.chapter-vii/section-2/article-87/5 5.chapter-vii/section-2/article-87/6 6.chapter-vii/section-2/article-87/7 7.chapter-vii/section-2/article-87/8 8.chapter-vii/section-2/article-87/9 9.chapter-vii/section-2/article-87/10 10.chapter-vii/section-2/article-87/11 11.chapter-vii/section-2/article-88 Article 88chapter-vii/section-2/article-88/1 1.chapter-vii/section-2/article-88/2 2.chapter-vii/section-2/article-89 Article 89chapter-vii/section-2/article-89/1 1.chapter-vii/section-2/article-89/2 2.chapter-vii/section-2/article-89/3 3.chapter-vii/section-2/article-89/4 4.chapter-vii/section-2/article-89/5 5.chapter-vii/section-2/article-89/6 6.chapter-vii/section-2/article-89/7 7.chapter-vii/section-2/article-89/8 8.chapter-vii/section-2/article-89/9 9.chapter-vii/section-2/article-89/10 10.chapter-vii/section-2/article-89/11 11.chapter-vii/section-2/article-90 Article 90chapter-vii/section-2/article-91 Article 91chapter-vii/section-2/article-92 Article 92chapter-vii/section-2/article-92/1 1.chapter-vii/section-2/article-92/2 2.chapter-vii/section-2/article-92/3 3.chapter-vii/section-2/article-92/4 4.chapter-vii/section-2/article-92/5 5.chapter-vii/section-2/article-92/6 6.chapter-vii/section-2/article-92/7 7.chapter-vii/section-2/article-92/8 8.chapter-vii/section-2/article-92/9 9.chapter-vii/section-3 SECTION 3chapter-vii/section-3/article-93 Article 93chapter-vii/section-3/article-93/1 1.chapter-vii/section-3/article-93/2 2.chapter-vii/section-3/article-93/3 3.chapter-vii/section-3/article-93/4 4.chapter-vii/section-3/article-93/5 5.chapter-vii/section-3/article-93/6 6.chapter-vii/section-3/article-93/7 7.chapter-vii/section-3/article-93/8 8.chapter-vii/section-3/article-93/9 9.chapter-vii/section-3/article-93/10 10.chapter-vii/section-3/article-93/11 11.chapter-vii/section-3/article-94 Article 94chapter-vii/section-3/article-95 Article 95chapter-vii/section-3/article-95/1 1.chapter-vii/section-3/article-95/2 2.chapter-vii/section-3/article-95/3 3.chapter-vii/section-3/article-95/4 4.chapter-vii/section-3/article-95/5 5.chapter-vii/section-3/article-95/6 6.chapter-vii/section-3/article-95/7 7.chapter-vii/section-3/article-96 Article 96chapter-vii/section-3/article-96/1 1.chapter-vii/section-3/article-96/2 2.chapter-vii/section-3/article-96/3 3.chapter-vii/section-3/article-97 Article 97chapter-vii/section-3/article-97/1 1.chapter-vii/section-3/article-97/2 2.chapter-vii/section-3/article-97/3 3.chapter-vii/section-3/article-98 Article 98chapter-vii/section-3/article-98/1 1.chapter-vii/section-3/article-98/2 2.chapter-vii/section-3/article-98/3 3.chapter-vii/section-3/article-98/4 4.chapter-vii/section-3/article-99 Article 99chapter-vii/section-3/article-99/1 1.chapter-vii/section-3/article-99/2 2.chapter-vii/section-3/article-99/3 3.chapter-vii/section-3/article-99/4 4.chapter-vii/section-3/article-100 Article 100chapter-vii/section-3/article-100/1 1.chapter-vii/section-3/article-100/2 2.chapter-vii/section-3/article-100/3 3.chapter-viii CHAPTER VIIIchapter-viii/article-101 Article 101chapter-viii/article-102 Article 102chapter-viii/article-102/1 1.chapter-viii/article-102/2 2.chapter-viii/article-103 Article 103chapter-viii/article-103/1 1.chapter-viii/article-103/2 2.chapter-viii/article-103/3 3.chapter-viii/article-103/4 4.chapter-viii/article-103/5 5.chapter-viii/article-103/6 6.chapter-viii/article-103/7 7.chapter-viii/article-103/8 8.chapter-viii/article-103/9 9.chapter-viii/article-104 Article 104chapter-viii/article-105 Article 105chapter-viii/article-106 Article 106chapter-viii/article-106/1 1.chapter-viii/article-106/2 2.chapter-viii/article-106/3 3.chapter-viii/article-106/4 4.chapter-viii/article-106/5 5.chapter-viii/article-106/6 6.chapter-viii/article-106/7 7.chapter-viii/article-106/8 8.chapter-viii/article-106/9 9.chapter-viii/article-106/10 10.chapter-viii/article-106/11 11.chapter-viii/article-106/12 12.chapter-viii/article-106/13 13.chapter-viii/article-106/14 14.chapter-viii/article-106/15 15.chapter-viii/article-107 Article 107chapter-viii/article-107/1 1.chapter-viii/article-107/2 2.chapter-viii/article-108 Article 108chapter-ix CHAPTER IXchapter-ix/article-109 Article 109chapter-ix/article-109/1 1.chapter-ix/article-109/2 2.chapter-ix/article-109/3 3.chapter-ix/article-109/4 4.chapter-ix/article-110 Article 110chapter-ix/article-110/1 1.chapter-ix/article-110/2 2.chapter-ix/article-111 Article 111chapter-ix/article-111/1 1.chapter-ix/article-111/2 2.chapter-ix/article-112 Article 112chapter-ix/article-113 Article 113chapter-x CHAPTER Xchapter-x/article-114 Article 114chapter-x/article-114/1 1.chapter-x/article-114/2 2.chapter-x/article-114/3 3.chapter-x/article-114/4 4.chapter-x/article-115 Article 115chapter-x/article-115/1 1.chapter-x/article-115/2 2.chapter-x/article-115/3 3.chapter-x/article-115/4 4.chapter-x/article-115/5 5.chapter-x/article-115/6 6.chapter-x/article-116 Article 116chapter-x/article-117 Article 117chapter-x/article-118 Article 118chapter-x/article-119 Article 119chapter-x/article-120 Article 120chapter-x/article-120/1 1.chapter-x/article-120/2 2.chapter-x/article-120/3 3.chapter-x/article-120/4 4.chapter-x/article-120/5 5.chapter-x/article-120/6 6.chapter-x/article-120/7 7.chapter-x/article-120/8 8.chapter-x/article-120/9 9.chapter-x/article-120/10 10.chapter-x/article-120/11 11.chapter-x/article-120/12 12.chapter-x/article-121 Article 121chapter-x/article-122 Article 122chapter-x/article-123 Article 123chapter-x/article-123/1 1.chapter-x/article-123/2 2.chapter-x/article-123/3 3.annex-i ANNEX Iannex-i/chapter-i CHAPTER Iannex-i/chapter-i/1 1.annex-i/chapter-i/2 2.annex-i/chapter-i/3 3.annex-i/chapter-i/4 4.annex-i/chapter-i/5 5.annex-i/chapter-i/6 6.annex-i/chapter-i/7 7.annex-i/chapter-i/8 8.annex-i/chapter-i/9 9.annex-i/chapter-ii CHAPTER IIannex-i/chapter-iii CHAPTER IIIannex-ii ANNEX IIannex-ii/1 1.annex-ii/1.1 1.1.annex-ii/1.2 1.2.annex-ii/2 2.annex-ii/3 3.annex-ii/4 4.annex-ii/5 5.annex-ii/6 6.annex-ii/6.1 6.1.annex-ii/6.2 6.2.annex-iii ANNEX IIIannex-iv ANNEX IVannex-iv/1 1.annex-iv/2 2.annex-iv/3 3.annex-iv/4 4.annex-iv/5 5.annex-iv/6 6.annex-iv/7 7.annex-iv/8 8.annex-iv/9 9.annex-iv/10 10.annex-v ANNEX Vannex-v/1 1.annex-v/2 2.annex-v/3 3.annex-vi ANNEX VIannex-vi/part-a PART Aannex-vi/part-a/1 1.annex-vi/part-a/2 2.annex-vi/part-a/2.1 2.1.annex-vi/part-b PART Bannex-vi/part-c PART Cannex-vi/part-c/1 1.annex-vi/part-c/2 2.annex-vi/part-c/2.1 2.1.annex-vi/part-c/2.2 2.2.annex-vi/part-c/2.3 2.3.annex-vi/part-c/2.4 2.4.annex-vi/part-c/3 3.annex-vi/part-c/3.1 3.1.annex-vi/part-c/3.2 3.2.annex-vi/part-c/3.3 3.3.annex-vi/part-c/3.4 3.4.annex-vi/part-c/3.5 3.5.annex-vi/part-c/3.6 3.6.annex-vi/part-c/3.7 3.7.annex-vi/part-c/3.8 3.8.annex-vi/part-c/3.9 3.9.annex-vi/part-c/3.10 3.10.annex-vi/part-c/4 4.annex-vi/part-c/4.1 4.1.annex-vi/part-c/4.2 4.2.annex-vi/part-c/4.3 4.3.annex-vi/part-c/4.4 4.4.annex-vi/part-c/4.5 4.5.annex-vi/part-c/4.6 4.6.annex-vi/part-c/4.7 4.7.annex-vi/part-c/4.8 4.8.annex-vi/part-c/4.9 4.9.annex-vi/part-c/4.10 4.10.annex-vi/part-c/4.11 4.11.annex-vi/part-c/4.12 4.12.annex-vi/part-c/4.13 4.13.annex-vi/part-c/4.14 4.14.annex-vi/part-c/4.15 4.15.annex-vi/part-c/5 5.annex-vi/part-c/5.1 5.1.annex-vi/part-c/5.2 5.2.annex-vi/part-c/5.3 5.3.annex-vi/part-c/5.4 5.4.annex-vi/part-c/5.5 5.5.annex-vi/part-c/5.6 5.6.annex-vi/part-c/5.7 5.7.annex-vi/part-c/5.8 5.8.annex-vi/part-c/5.9 5.9.annex-vi/part-c/5.10 5.10.annex-vi/part-c/5.11 5.11.annex-vi/part-c/6 6.annex-vi/part-c/6.1 6.1.annex-vi/part-c/6.1.1 6.1.1.annex-vi/part-c/6.1.2 6.1.2.annex-vi/part-c/6.1.3 6.1.3.annex-vi/part-c/6.2 6.2.annex-vi/part-c/6.2.1 6.2.1.annex-vi/part-c/6.2.2 6.2.2.annex-vi/part-c/6.3 6.3.annex-vi/part-c/6.3.1 6.3.1.annex-vi/part-c/6.3.2 6.3.2.annex-vi/part-c/6.3.3 6.3.3.annex-vi/part-c/6.4 6.4.annex-vi/part-c/6.4.1 6.4.1.annex-vi/part-c/6.4.2 6.4.2.annex-vi/part-c/6.4.3 6.4.3.annex-vi/part-c/6.4.4 6.4.4.annex-vi/part-c/6.4.5 6.4.5.annex-vi/part-c/6.5 6.5.annex-vi/part-c/6.5.1 6.5.1.annex-vi/part-c/6.5.2 6.5.2.annex-vi/part-c/6.5.3 6.5.3.annex-vi/part-c/6.5.4 6.5.4.annex-vii ANNEX VIIannex-vii/1 1.annex-vii/1.1 1.1.annex-vii/1.1.1 1.1.1.annex-vii/1.1.2 1.1.2.annex-vii/1.1.3 1.1.3.annex-vii/1.1.4 1.1.4.annex-vii/1.1.5 1.1.5.annex-vii/1.1.6 1.1.6.annex-vii/1.2 1.2.annex-vii/1.2.1 1.2.1.annex-vii/1.2.2 1.2.2.annex-vii/1.2.3 1.2.3.annex-vii/1.2.4 1.2.4.annex-vii/1.2.5 1.2.5.annex-vii/1.2.6 1.2.6.annex-vii/1.2.7 1.2.7.annex-vii/1.2.8 1.2.8.annex-vii/1.2.9 1.2.9.annex-vii/1.3 1.3.annex-vii/1.3.1 1.3.1.annex-vii/1.3.2 1.3.2.annex-vii/1.4 1.4.annex-vii/1.4.1 1.4.1.annex-vii/1.4.2 1.4.2.annex-vii/1.5 1.5.annex-vii/1.6 1.6.annex-vii/1.6.1 1.6.1.annex-vii/1.6.2 1.6.2.annex-vii/2 2.annex-vii/2.1 2.1.annex-vii/2.2 2.2.annex-vii/2.3 2.3.annex-vii/2.4 2.4.annex-vii/3 3.annex-vii/3.1 3.1.annex-vii/3.1.1 3.1.1.annex-vii/3.1.2 3.1.2.annex-vii/3.1.3 3.1.3.annex-vii/3.2 3.2.annex-vii/3.2.1 3.2.1.annex-vii/3.2.2 3.2.2.annex-vii/3.2.3 3.2.3.annex-vii/3.2.4 3.2.4.annex-vii/3.2.5 3.2.5.annex-vii/3.2.6 3.2.6.annex-vii/3.2.7 3.2.7.annex-vii/3.3 3.3.annex-vii/3.3.1 3.3.1.annex-vii/3.3.2 3.3.2.annex-vii/3.4 3.4.annex-vii/3.4.1 3.4.1.annex-vii/3.4.2 3.4.2.annex-vii/3.4.3 3.4.3.annex-vii/3.5 3.5.annex-vii/3.5.1 3.5.1.annex-vii/3.5.2 3.5.2.annex-vii/4 4.annex-vii/4.1 4.1.annex-vii/4.2 4.2.annex-vii/4.3 4.3.annex-vii/4.4 4.4.annex-vii/4.5 4.5.annex-vii/4.5.1 4.5.1.annex-vii/4.5.2 4.5.2.annex-vii/4.5.3 4.5.3.annex-vii/4.5.4 4.5.4.annex-vii/4.5.5 4.5.5.annex-vii/4.5.6 4.5.6.annex-vii/4.6 4.6.annex-vii/4.7 4.7.annex-vii/4.8 4.8.annex-vii/4.9 4.9.annex-vii/4.10 4.10.annex-vii/4.11 4.11.annex-viii ANNEX VIIIannex-viii/chapter-i CHAPTER Iannex-viii/chapter-i/1 1.annex-viii/chapter-i/2 2.annex-viii/chapter-ii CHAPTER IIannex-viii/chapter-iii CHAPTER IIIannex-ix ANNEX IXannex-ix/chapter-i CHAPTER Iannex-ix/chapter-i/1 1.annex-ix/chapter-i/2 2.annex-ix/chapter-i/2.1 2.1.annex-ix/chapter-i/2.2 2.2.annex-ix/chapter-i/2.3 2.3.annex-ix/chapter-i/2.4 2.4.annex-ix/chapter-i/3 3.annex-ix/chapter-i/3.1 3.1.annex-ix/chapter-i/3.2 3.2.annex-ix/chapter-i/3.3 3.3.annex-ix/chapter-i/3.4 3.4.annex-ix/chapter-i/3.5 3.5.annex-ix/chapter-i/3.6 3.6.annex-ix/chapter-i/3.7 3.7.annex-ix/chapter-ii CHAPTER IIannex-ix/chapter-iii CHAPTER IIIannex-x ANNEX Xannex-x/1 1.annex-x/2 2.annex-x/3 3.annex-x/4 4.annex-x/5 5.annex-x/5.1 5.1.annex-x/5.2 5.2.annex-x/5.3 5.3.annex-x/6 6.annex-x/7 7.annex-xi ANNEX XIannex-xi/1 1.annex-xi/2 2.annex-xi/3 3.annex-xi/part-a PART Aannex-xi/part-b PART Bannex-xii ANNEX XIIannex-xii/chapter-i CHAPTER Iannex-xii/chapter-i/1 1.annex-xii/chapter-i/2 2.annex-xii/chapter-i/3 3.annex-xii/chapter-i/4 4.annex-xii/chapter-i/5 5.annex-xii/chapter-i/6 6.annex-xii/chapter-i/7 7.annex-xii/chapter-i/8 8.annex-xii/chapter-ii CHAPTER IIannex-xiii ANNEX XIIIannex-xiii/1 1.annex-xiii/2 2.annex-xiii/3 3.annex-xiii/4 4.annex-xiii/5 5.annex-xiv ANNEX XIVannex-xiv/part-a PART Aannex-xiv/part-a/1 1.annex-xiv/part-a/2 2.annex-xiv/part-a/3 3.annex-xiv/part-a/4 4.annex-xiv/part-b PART Bannex-xv ANNEX XVannex-xv/chapter-i CHAPTER Iannex-xv/chapter-i/1 1.annex-xv/chapter-i/2 2.annex-xv/chapter-i/2.1 2.1.annex-xv/chapter-i/2.2 2.2.annex-xv/chapter-i/2.3 2.3.annex-xv/chapter-i/2.4 2.4.annex-xv/chapter-i/2.5 2.5.annex-xv/chapter-i/2.6 2.6.annex-xv/chapter-i/2.7 2.7.annex-xv/chapter-i/2.8 2.8.annex-xv/chapter-ii CHAPTER IIannex-xv/chapter-ii/1 1.annex-xv/chapter-ii/2 2.annex-xv/chapter-ii/2.1 2.1.annex-xv/chapter-ii/2.2 2.2.annex-xv/chapter-ii/2.3 2.3.annex-xv/chapter-ii/2.4 2.4.annex-xv/chapter-ii/2.5 2.5.annex-xv/chapter-ii/2.6 2.6.annex-xv/chapter-ii/2.7 2.7.annex-xv/chapter-ii/2.8 2.8.annex-xv/chapter-ii/3 3.annex-xv/chapter-ii/3.1 3.1.annex-xv/chapter-ii/3.1.1 3.1.1.annex-xv/chapter-ii/3.1.2 3.1.2.annex-xv/chapter-ii/3.1.3 3.1.3.annex-xv/chapter-ii/3.1.4 3.1.4.annex-xv/chapter-ii/3.1.5 3.1.5.annex-xv/chapter-ii/3.2 3.2.annex-xv/chapter-ii/3.3 3.3.annex-xv/chapter-ii/3.4 3.4.annex-xv/chapter-ii/3.5 3.5.annex-xv/chapter-ii/3.6 3.6.annex-xv/chapter-ii/3.6.1 3.6.1.annex-xv/chapter-ii/3.6.2 3.6.2.annex-xv/chapter-ii/3.6.3 3.6.3.annex-xv/chapter-ii/3.6.4 3.6.4.annex-xv/chapter-ii/3.6.5 3.6.5.annex-xv/chapter-ii/3.6.6 3.6.6.annex-xv/chapter-ii/3.7 3.7.annex-xv/chapter-ii/3.8 3.8.annex-xv/chapter-ii/3.9 3.9.annex-xv/chapter-ii/3.10 3.10.annex-xv/chapter-ii/3.11 3.11.annex-xv/chapter-ii/3.12 3.12.annex-xv/chapter-ii/3.13 3.13.annex-xv/chapter-ii/3.14 3.14.annex-xv/chapter-ii/3.15 3.15.annex-xv/chapter-ii/3.16 3.16.annex-xv/chapter-ii/3.17 3.17.annex-xv/chapter-ii/3.18 3.18.annex-xv/chapter-ii/3.19 3.19.annex-xv/chapter-ii/4 4.annex-xv/chapter-ii/4.1 4.1.annex-xv/chapter-ii/4.2 4.2.annex-xv/chapter-ii/4.3 4.3.annex-xv/chapter-ii/4.4 4.4.annex-xv/chapter-ii/4.5 4.5.annex-xv/chapter-ii/4.6 4.6.annex-xv/chapter-iii CHAPTER IIIannex-xv/chapter-iii/1 1.annex-xv/chapter-iii/2 2.annex-xv/chapter-iii/3 3.annex-xv/chapter-iii/4 4.annex-xv/chapter-iii/5 5.annex-xv/chapter-iii/6 6.annex-xv/chapter-iii/7 7.annex-xvi ANNEX XVIannex-xvi/1 1.annex-xvi/2 2.annex-xvi/3 3.annex-xvi/4 4.annex-xvi/5 5.annex-xvi/6 6.annex-xvii ANNEX XVIIDefinitions: 81 read in this text, 7 with the text quoted and 74 with the text withheld.
(1) medical device under chapter-i/article-2: text withheld (over the cap: its term and text are 183 words)(2) accessory for a medical device under chapter-i/article-2: text withheld (over the cap: its term and text are 66 words)(3) custom-made device under chapter-i/article-2: text withheld (over the cap: its term and text are 101 words)(4) active device under chapter-i/article-2: text withheld (over the cap: its term and text are 79 words)(5) implantable device under chapter-i/article-2: text withheld (over the cap: its term and text are 89 words)(6) invasive device under chapter-i/article-2: text withheld (over the cap: its term and text are 27 words)(7) generic device group under chapter-i/article-2: text withheld (over the cap: its term and text are 33 words)(8) single-use device under chapter-i/article-2: text withheld (over the cap: its term and text are 18 words)(9) falsified device under chapter-i/article-2: text withheld (over the cap: its term and text are 45 words)(10) procedure pack under chapter-i/article-2: text withheld (over the cap: its term and text are 25 words)(11) system under chapter-i/article-2: text withheld (over the cap: its term and text are 25 words)(12) intended purpose under chapter-i/article-2: text withheld (over the cap: its term and text are 45 words)(13) label under chapter-i/article-2: text withheld (over the cap: its term and text are 28 words)(14) instructions for use under chapter-i/article-2: text withheld (over the cap: its term and text are 29 words)(15) Unique Device Identifier under chapter-i/article-2: text withheld (over the cap: its term and text are 34 words)(15) UDI under chapter-i/article-2: text withheld (over the cap: its term and text are 34 words)(16) non-viable under chapter-i/article-2: having no potential for metabolism or multiplication;(17) derivative under chapter-i/article-2: text withheld (over the cap: its term and text are 36 words)(18) nanomaterial under chapter-i/article-2: text withheld (over the cap: its term and text are 72 words)(19) particle under chapter-i/article-2: text withheld (over the cap: its term and text are 22 words)(20) agglomerate under chapter-i/article-2: text withheld (over the cap: its term and text are 40 words)(21) aggregate under chapter-i/article-2: text withheld (over the cap: its term and text are 22 words)(22) performance under chapter-i/article-2: text withheld (over the cap: its term and text are 17 words)(23) risk under chapter-i/article-2: text withheld (over the cap: its term and text are 17 words)(24) benefit-risk determination under chapter-i/article-2: text withheld (end not delimited: a number and a quoted term that these rules do not read as a definition lie before the next definition read)(27) making available on the market under chapter-i/article-2: text withheld (over the cap: its term and text are 41 words)(28) placing on the market under chapter-i/article-2: text withheld (over the cap: its term and text are 21 words)(29) putting into service under chapter-i/article-2: text withheld (over the cap: its term and text are 40 words)(30) manufacturer under chapter-i/article-2: text withheld (over the cap: its term and text are 32 words)(31) fully refurbishing under chapter-i/article-2: text withheld (over the cap: its term and text are 56 words)(32) authorised representative under chapter-i/article-2: text withheld (over the cap: its term and text are 47 words)(33) importer under chapter-i/article-2: text withheld (over the cap: its term and text are 23 words)(34) distributor under chapter-i/article-2: text withheld (over the cap: its term and text are 34 words)(35) economic operator under chapter-i/article-2: text withheld (over the cap: its term and text are 22 words)(36) health institution under chapter-i/article-2: text withheld (over the cap: its term and text are 23 words)(37) user under chapter-i/article-2: any healthcare professional or lay person who uses a device;(38) lay person under chapter-i/article-2: text withheld (over the cap: its term and text are 20 words)(39) reprocessing under chapter-i/article-2: text withheld (over the cap: its term and text are 39 words)(40) conformity assessment under chapter-i/article-2: text withheld (over the cap: its term and text are 19 words)(41) conformity assessment body under chapter-i/article-2: text withheld (over the cap: its term and text are 18 words)(42) notified body under chapter-i/article-2: a conformity assessment body designated in accordance with this Regulation;(43) CE marking of conformity under chapter-i/article-2: text withheld (over the cap: its term and text are 40 words)(43) CE marking under chapter-i/article-2: text withheld (over the cap: its term and text are 40 words)(44) clinical evaluation under chapter-i/article-2: text withheld (over the cap: its term and text are 43 words)(45) clinical investigation under chapter-i/article-2: text withheld (over the cap: its term and text are 22 words)(46) investigational device under chapter-i/article-2: a device that is assessed in a clinical investigation;(47) clinical investigation plan under chapter-i/article-2: text withheld (over the cap: its term and text are 23 words)(48) clinical data under chapter-i/article-2: text withheld (over the cap: its term and text are 100 words)(49) sponsor under chapter-i/article-2: text withheld (over the cap: its term and text are 27 words)(50) subject under chapter-i/article-2: an individual who participates in a clinical investigation;(51) clinical evidence under chapter-i/article-2: text withheld (over the cap: its term and text are 43 words)(52) clinical performance under chapter-i/article-2: text withheld (over the cap: its term and text are 52 words)(53) clinical benefit under chapter-i/article-2: text withheld (over the cap: its term and text are 40 words)(54) investigator under chapter-i/article-2: text withheld (over the cap: its term and text are 17 words)(55) informed consent under chapter-i/article-2: text withheld (over the cap: its term and text are 67 words)(56) ethics committee under chapter-i/article-2: text withheld (over the cap: its term and text are 44 words)(57) adverse event under chapter-i/article-2: text withheld (over the cap: its term and text are 42 words)(58) serious adverse event under chapter-i/article-2: text withheld (over the cap: its term and text are 95 words)(59) device deficiency under chapter-i/article-2: text withheld (over the cap: its term and text are 30 words)(60) post-market surveillance under chapter-i/article-2: text withheld (over the cap: its term and text are 64 words)(61) market surveillance under chapter-i/article-2: text withheld (over the cap: its term and text are 45 words)(62) recall under chapter-i/article-2: text withheld (over the cap: its term and text are 22 words)(63) withdrawal under chapter-i/article-2: text withheld (over the cap: its term and text are 21 words)(64) incident under chapter-i/article-2: text withheld (over the cap: its term and text are 41 words)(65) serious incident under chapter-i/article-2: text withheld (over the cap: its term and text are 54 words)(66) serious public health threat under chapter-i/article-2: text withheld (over the cap: its term and text are 54 words)(67) corrective action under chapter-i/article-2: text withheld (over the cap: its term and text are 19 words)(68) field safety corrective action under chapter-i/article-2: text withheld (over the cap: its term and text are 36 words)(69) field safety notice under chapter-i/article-2: text withheld (over the cap: its term and text are 22 words)(70) harmonised standard under chapter-i/article-2: text withheld (end not delimited: a heading the clause anchors read lies between it and the next definition read)1.1. Transient under annex-viii/chapter-i/1: normally intended for continuous use for less than 60 minutes.1.2. Short term under annex-viii/chapter-i/1: text withheld (over the cap: its term and text are 15 words)1.3. Long term under annex-viii/chapter-i/1: text withheld (end not delimited: a heading the clause anchors read lies between it and the next definition read)2.1. Body orifice under annex-viii/chapter-i/2: text withheld (over the cap: its term and text are 27 words)2.2. Surgically invasive device under annex-viii/chapter-i/2: text withheld (over the cap: its term and text are 50 words)2.3. Reusable surgical instrument under annex-viii/chapter-i/2: text withheld (over the cap: its term and text are 52 words)2.4. Active therapeutic device under annex-viii/chapter-i/2: text withheld (over the cap: its term and text are 39 words)2.5. Active device intended for diagnosis and monitoring under annex-viii/chapter-i/2: text withheld (over the cap: its term and text are 38 words)2.6. Central circulatory system under annex-viii/chapter-i/2: text withheld (over the cap: its term and text are 58 words)2.7. Central nervous system under annex-viii/chapter-i/2: the brain, meninges and spinal cord.2.8. Injured skin or mucous membrane under annex-viii/chapter-i/2: text withheld (end not delimited: no definition is read after it in this text)Sentences printing a listed verb: 1728 read in this text, 141 quoted and 1587 withheld.
chapter-i/article-1/2 The necessary common specifications shall be adopted by 26 May 2020.chapter-i/article-1/13 This Regulation shall not affect the application of Directive 2013/59/Euratom.chapter-ii/article-5/5 This paragraph shall not apply to devices that are manufactured on an industrial scale.chapter-ii/article-10/4 The technical documentation shall include the elements set out in Annexes II and III.chapter-ii/article-13/4 Importers shall add their details to the registration in accordance with Article 31.chapter-ii/article-17/3 The Commission shall keep the information publicly available.chapter-ii/article-17/9 The Commission shall make such information publicly available.chapter-ii/article-19/1 The manufacturer shall continuously update the EU declaration of conformity.chapter-ii/article-20/4 The CE marking shall be affixed before the device is placed on the market.chapter-ii/article-22/5 Where those periods differ, the longest period shall apply.chapter-ii/article-23/1 Supporting evidence shall be kept available for the competent authorities of the Member States.chapter-iii/article-27/4 Higher levels of packaging shall not be understood to include shipping containers.chapter-iii/article-30/3 Importers shall add their details to the relevant entry/entries.chapter-iii/article-32/1 After its validation, the notified body shall upload the summary to Eudamed.chapter-iii/article-33/4 The Commission shall provide for technical and administrative support to users of Eudamed.chapter-iv/article-36/1 In particular, notified bodies shall comply with Annex VII.chapter-iv/article-37/3 Notified bodies shall make publicly available a list of their subsidiaries.chapter-iv/article-39/1 Once the application is complete that authority shall send it to the Commission.chapter-iv/article-42/11 The designation shall become valid the day after the notification is published in NANDO.chapter-iv/article-43/2 The Commission shall ensure that the list is kept up to date.chapter-iv/article-45/3 Such reviews shall be conducted utilising CS.chapter-iv/article-45/4 The reviews shall be conducted utilising appropriate expertise.chapter-iv/article-46/2 The Commission shall immediately publish the amended notification in NANDO.chapter-iv/article-47/3 The reporting and outcome of that assessment shall follow the principles of Article 39.chapter-iv/article-49 This group shall meet on a regular basis and at least annually.chapter-iv/article-49 The bodies notified under this Regulation shall participate in the work of that group.chapter-v/section-1/article-51/1 Classification shall be carried out in accordance with Annex VIII.chapter-v/section-1/article-51/2 The decision shall be made available upon request.chapter-v/section-2/article-54/3 That notification shall be accompanied by the clinical evaluation assessment report.chapter-v/section-2/article-56/1 The minimum content of the certificates shall be as set out in Annex XII.chapter-v/section-2/article-56/4 The notified body shall give the reasons for its decision.chapter-v/section-2/article-56/5 Such information shall be accessible to the public.chapter-vi/article-61/2 The manufacturer shall give due consideration to the views expressed by the expert panel.chapter-vi/article-62/3 Clinical investigations shall be subject to scientific and ethical review.chapter-vi/article-63/2 In that case, the witness shall sign and date the informed consent document.chapter-vi/article-63/2 The informed consent shall be documented.chapter-vi/article-64/2 The subject shall as far as possible take part in the informed consent procedure.chapter-vi/article-73/4 No personal data of subjects shall be publicly available.chapter-vi/article-75/1 Changes to the relevant documentation shall be clearly identifiable.chapter-vi/article-76/2 That opinion shall be delivered within seven days.chapter-vi/article-78/10 That Member State shall provide for an appeal procedure in respect of such refusal.chapter-vi/article-78/14 After 27 May 2027, all Member States shall be required to apply that procedure.chapter-vi/article-80/2 The period for reporting shall take account of the severity of the event.chapter-vii/section-1/article-83/3 The technical documentation shall be updated accordingly.chapter-vii/section-2/article-89/4 The competent authority shall monitor the manufacturer's investigation of a serious incident.chapter-vii/section-2/article-92/1 That electronic system shall include relevant links to the UDI database.chapter-vii/section-3/article-93/6 The report shall set out any corrective actions needed.chapter-vii/section-3/article-93/8 The Member States shall review and assess the functioning of their market surveillance activities.chapter-vii/section-3/article-94 The relevant economic operators shall cooperate with the competent authorities.chapter-vii/section-3/article-99/1 Where the measure is of general applicability, it shall be appropriately published.chapter-viii/article-103/2 They shall represent the competent authorities of the Member States.chapter-viii/article-103/2 The names and affiliation of members shall be made public by the Commission.chapter-viii/article-103/2 The alternates shall represent and vote for the members in their absence.chapter-viii/article-103/4 The MDCG shall use its best endeavours to reach consensus.chapter-viii/article-103/5 The MDCG shall be chaired by a representative of the Commission.chapter-viii/article-103/5 The chair shall not take part in votes of the MDCG.chapter-viii/article-103/7 The MDCG may establish standing or temporary sub-groups.chapter-viii/article-106/2 Expert panels and expert laboratories may be appointed on a standing or temporary basis.chapter-viii/article-106/3 The members of expert panels shall perform their tasks with impartiality and objectivity.chapter-viii/article-106/3 They shall neither seek nor take instructions from notified bodies or manufacturers.chapter-viii/article-106/6 That list shall be published on the Commission website.chapter-viii/article-107/1 They shall undertake to act in the public interest and in an independent manner.chapter-viii/article-107/1 The declaration of interests shall be made publicly available on the Commission website.chapter-ix/article-111/2 The structure and level of fees shall be made publicly available on request.chapter-ix/article-113 The penalties provided for shall be effective, proportionate, and dissuasive.chapter-x/article-114/1 The Commission shall be assisted by a Committee on Medical Devices.chapter-x/article-114/1 That Committee shall be a committee within the meaning of Regulation (EU) No 182/2011.chapter-x/article-115/3 It shall not affect the validity of any delegated acts already in force.chapter-x/article-120/2 They shall however become void at the latest on 27 May 2024.chapter-x/article-123/2 It shall apply from 26 May 2020.annex-i/chapter-i/3 Manufacturers shall establish, implement, document and maintain a risk management system.annex-i/chapter-i/4 Manufacturers shall inform users of any residual risks.annex-i/chapter-ii Special attention shall be given to nanomaterials.annex-i/chapter-ii Where necessary devices shall be designed to facilitate their safe cleaning, disinfection, and/or re-sterilisation.annex-i/chapter-ii Such procedures shall be described in the instructions for use.annex-i/chapter-ii The limits of accuracy shall be indicated by the manufacturer.annex-i/chapter-ii The function of the controls and indicators shall be clearly specified on the devices.annex-i/chapter-iii Any symbol or identification colour used shall conform to the harmonised standards or CS.annex-v/1 The CE marking shall consist of the initials ‘CE’ taking the following form:annex-v/3 This minimum dimension may be waived for small-scale devices.annex-vi/part-c/1 Those individual components may be devices in themselves.annex-vi/part-c/1 The combination of items may be modified, adjusted or customized to meet specific needs.annex-vi/part-c/2.2 The manufacturer shall assign and maintain unique UDIs for its devices.annex-vi/part-c/2.3 Only the manufacturer may place the UDI on the device or its packaging.annex-vi/part-c/3.1 A UDI shall be assigned to the device itself or its packaging.annex-vi/part-c/3.1 Higher levels of packaging shall have their own UDI.annex-vi/part-c/3.2 Shipping containers shall be exempted from the requirement in Section 3.1.annex-vi/part-c/3.3 The UDI shall contain two parts: a UDI-DI and a UDI-PI.annex-vi/part-c/3.4 The UDI-DI shall be unique at each level of device packaging.annex-vi/part-c/3.8 The manufacturer shall assign the UDI to a device following the relevant coding standard.annex-vi/part-c/4.6 All parts and elements of the linear bar code shall be distinguishable and identifiable.annex-vi/part-c/4.8 The HRI format shall follow the rules of the UDI code-issuing entity.annex-vi/part-c/4.10 Devices that are reusable shall bear a UDI carrier on the device itself.annex-vi/part-c/5.3 Appropriate methods/procedures for validation of the data provided shall be implemented.annex-vi/part-c/5.10 The use of free-text fields shall, however, be minimized in order to reduce translations.annex-vi/part-c/6.1.3 The UDI of the implantable device shall be identifiable prior to implantation.annex-vi/part-c/6.4.3 A configurable device UDI-PI shall be assigned to each individual configurable device.annex-vi/part-c/6.5.3 Minor software revisions shall require a new UDI-PI and not a new UDI-DI.annex-vi/part-c/6.5.3 Minor software revisions shall be identified by a manufacturer-specific form of identification.annex-vii/1.1.1 Its legal personality and status shall be fully documented.annex-vii/1.2.2 The investigation, outcome and its resolution shall be documented.annex-vii/1.2.5 Notified bodies shall make publicly available the declarations of interest of their top-level management.annex-vii/1.3.2 Proprietary rights shall be protected.annex-vii/1.6.2 The notified body shall take into consideration guidance and best practice documents.annex-vii/4.3 It shall be kept by the notified body.annex-vii/4.3 The outcome of each review of an application shall be documented.annex-vii/4.10 The results of the evaluation and any decisions taken shall be thoroughly documented.annex-ix/chapter-i/2.2 Implementation of the quality management system shall ensure compliance with this Regulation.annex-ix/chapter-i/2.3 The notified body in question shall document its rationale for the samples taken.annex-ix/chapter-i/2.3 The notified body shall notify the manufacturer of its decision to issue the certificate.annex-ix/chapter-i/2.3 The decision shall contain the conclusions of the audit and a reasoned report.annex-ix/chapter-ii The application shall describe the design, manufacture and performance of the device in question.annex-ix/chapter-ii It shall include the technical documentation as referred to in Annexes II and III.annex-ix/chapter-ii The notified body shall not deliver the certificate if that scientific opinion is unfavourable.annex-x/2 Application The manufacturer shall lodge an application for assessment with a notified body.annex-x/4 The certificate shall be drawn up in accordance with Annex XII.annex-x/7 Section 8 of Annex IX shall apply.annex-xi/part-a The first and second paragraph of Section 2.3 of Annex IX shall apply.annex-xi/part-a The notified body shall notify the manufacturer of its decision to issue the certificate.annex-xi/part-a Section 2.4 of Annex IX shall apply.annex-xi/part-a Section 8 of Annex IX shall apply.annex-xi/part-a Section 8 of Annex IX shall apply.annex-xi/part-b Section 8 of Annex IX shall apply.annex-xi/part-b Section 8 of Annex IX shall apply.annex-xii/chapter-i/1 Certificates shall be drawn up in one of the official languages of the Union.annex-xii/chapter-i/2 Each certificate shall refer to only one conformity assessment procedure.annex-xii/chapter-i/3 Certificates shall only be issued to one manufacturer.annex-xiii/4 In the case of implantable devices, the period shall be at least 15 years.annex-xiii/4 Section 8 of Annex IX shall apply.annex-xiv/part-a/3 Considerations of equivalence shall be based on proper scientific justification.annex-xv/chapter-i/2.6 The endpoints shall be determined and assessed using scientifically valid methodologies.annex-xv/chapter-i/2.6 The primary endpoint shall be appropriate to the device and clinically relevant.annex-xv/chapter-i/2.7 Investigators shall have access to the technical and clinical data regarding the device.annex-xv/chapter-ii/2 The IB shall be clearly identified and contain in particular the following information:annex-xv/chapter-ii/3 It shall contain in particular the information as laid down in this Annex.annex-xv/chapter-ii/3.15 Such procedures shall for implantable devices, cover as a minimum traceability.annex-xv/chapter-iii/3 In the case of implantable devices, the period shall be at least 15 years.annex-xv/chapter-iii/5 The Sponsor shall complete the follow-up of investigation subjects.chapter-i/article-1/2 4 withheld: over the quote capchapter-i/article-1/3 1 withheld: over the quote capchapter-i/article-1/4 1 withheld: over the quote capchapter-i/article-1/6 1 withheld: over the quote capchapter-i/article-1/7 2 withheld: over the quote capchapter-i/article-1/8 3 withheld: over the quote capchapter-i/article-1/9 3 withheld: over the quote capchapter-i/article-1/10 4 withheld: over the quote capchapter-i/article-1/12 1 withheld: over the quote capchapter-i/article-1/14 1 withheld: over the quote capchapter-i/article-1/15 1 withheld: over the quote capchapter-i/article-1/16 1 withheld: over the quote capchapter-i/article-2 7 withheld: over the quote capchapter-i/article-4/1 2 withheld: over the quote capchapter-i/article-4/2 2 withheld: over the quote capchapter-i/article-4/3 1 withheld: over the quote capchapter-i/article-4/4 1 withheld: over the quote capchapter-ii/article-5/1 1 withheld: over the quote capchapter-ii/article-5/2 1 withheld: over the quote capchapter-ii/article-5/3 1 withheld: over the quote capchapter-ii/article-5/4 1 withheld: over the quote capchapter-ii/article-5/5 3 withheld: over the quote capchapter-ii/article-5/6 2 withheld: over the quote capchapter-ii/article-6/1 1 withheld: over the quote capchapter-ii/article-6/2 1 withheld: over the quote capchapter-ii/article-6/3 1 withheld: over the quote capchapter-ii/article-6/4 1 withheld: over the quote capchapter-ii/article-7 1 withheld: over the quote capchapter-ii/article-8/1 3 withheld: over the quote capchapter-ii/article-8/2 1 withheld: over the quote capchapter-ii/article-9/1 2 withheld: over the quote capchapter-ii/article-9/2 1 withheld: over the quote capchapter-ii/article-9/3 1 withheld: over the quote capchapter-ii/article-9/4 1 withheld: over the quote capchapter-ii/article-10/1 1 withheld: over the quote capchapter-ii/article-10/2 1 withheld: over the quote capchapter-ii/article-10/3 1 withheld: over the quote capchapter-ii/article-10/4 2 withheld: over the quote capchapter-ii/article-10/5 1 withheld: over the quote capchapter-ii/article-10/6 1 withheld: over the quote capchapter-ii/article-10/7 1 withheld: over the quote capchapter-ii/article-10/8 4 withheld: over the quote capchapter-ii/article-10/9 6 withheld: over the quote capchapter-ii/article-10/10 1 withheld: over the quote capchapter-ii/article-10/11 2 withheld: over the quote capchapter-ii/article-10/12 3 withheld: over the quote capchapter-ii/article-10/13 1 withheld: over the quote capchapter-ii/article-10/14 5 withheld: over the quote capchapter-ii/article-10/15 1 withheld: over the quote capchapter-ii/article-10/16 2 withheld: over the quote capchapter-ii/article-11/1 1 withheld: over the quote capchapter-ii/article-11/2 1 withheld: over the quote capchapter-ii/article-11/3 3 withheld: over the quote capchapter-ii/article-11/4 1 withheld: over the quote capchapter-ii/article-11/5 1 withheld: over the quote capchapter-ii/article-11/6 1 withheld: over the quote capchapter-ii/article-11/7 1 withheld: over the quote capchapter-ii/article-12 2 withheld: over the quote capchapter-ii/article-13/1 1 withheld: over the quote capchapter-ii/article-13/2 3 withheld: over the quote capchapter-ii/article-13/3 2 withheld: over the quote capchapter-ii/article-13/4 1 withheld: over the quote capchapter-ii/article-13/5 1 withheld: over the quote capchapter-ii/article-13/6 1 withheld: over the quote capchapter-ii/article-13/7 3 withheld: over the quote capchapter-ii/article-13/8 1 withheld: over the quote capchapter-ii/article-13/9 1 withheld: over the quote capchapter-ii/article-13/10 2 withheld: over the quote capchapter-ii/article-14/1 1 withheld: over the quote capchapter-ii/article-14/2 4 withheld: over the quote capchapter-ii/article-14/3 1 withheld: over the quote capchapter-ii/article-14/4 3 withheld: over the quote capchapter-ii/article-14/5 2 withheld: over the quote capchapter-ii/article-14/6 4 withheld: over the quote capchapter-ii/article-15/1 3 withheld: over the quote capchapter-ii/article-15/2 1 withheld: over the quote capchapter-ii/article-15/3 1 withheld: over the quote capchapter-ii/article-15/4 1 withheld: over the quote capchapter-ii/article-15/5 1 withheld: over the quote capchapter-ii/article-15/6 2 withheld: over the quote capchapter-ii/article-16/1 2 withheld: over the quote capchapter-ii/article-16/2 2 withheld: over the quote capchapter-ii/article-16/3 3 withheld: over the quote capchapter-ii/article-16/4 2 withheld: over the quote capchapter-ii/article-17/1 1 withheld: over the quote capchapter-ii/article-17/2 2 withheld: over the quote capchapter-ii/article-17/3 3 withheld: over the quote capchapter-ii/article-17/4 1 withheld: over the quote capchapter-ii/article-17/5 4 withheld: over the quote capchapter-ii/article-17/6 1 withheld: over the quote capchapter-ii/article-17/7 1 withheld: over the quote capchapter-ii/article-17/8 2 withheld: over the quote capchapter-ii/article-17/9 2 withheld: over the quote capchapter-ii/article-17/10 2 withheld: over the quote capchapter-ii/article-18/1 5 withheld: over the quote capchapter-ii/article-18/2 1 withheld: over the quote capchapter-ii/article-18/3 1 withheld: over the quote capchapter-ii/article-19/1 2 withheld: over the quote capchapter-ii/article-19/2 2 withheld: over the quote capchapter-ii/article-19/3 1 withheld: over the quote capchapter-ii/article-20/1 1 withheld: over the quote capchapter-ii/article-20/2 1 withheld: over the quote capchapter-ii/article-20/3 3 withheld: over the quote capchapter-ii/article-20/4 1 withheld: over the quote capchapter-ii/article-20/5 2 withheld: over the quote capchapter-ii/article-20/6 1 withheld: over the quote capchapter-ii/article-21/1 2 withheld: over the quote capchapter-ii/article-21/2 2 withheld: over the quote capchapter-ii/article-21/3 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over the quote capannex-x/3 6 withheld: over the quote capannex-x/4 3 withheld: over the quote capannex-x/5.1 1 withheld: over the quote capannex-x/5.2 3 withheld: over the quote capannex-x/5.3 1 withheld: over the quote capannex-x/6 1 withheld: over the quote capannex-x/7 1 withheld: over the quote capannex-xi/2 1 withheld: over the quote capannex-xi/3 1 withheld: over the quote capannex-xi/part-a 21 withheld: over the quote capannex-xi/part-b 14 withheld: over the quote capannex-xii/chapter-i/3 1 withheld: over the quote capannex-xii/chapter-i/4 1 withheld: over the quote capannex-xii/chapter-i/5 2 withheld: over the quote capannex-xii/chapter-i/6 1 withheld: over the quote capannex-xii/chapter-i/7 1 withheld: over the quote capannex-xii/chapter-i/8 1 withheld: over the quote capannex-xiii/1 1 withheld: over the quote capannex-xiii/2 1 withheld: over the quote capannex-xiii/3 1 withheld: over the quote capannex-xiii/4 1 withheld: over the quote capannex-xiii/5 1 withheld: over the 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capannex-xv/chapter-ii/4.2 1 withheld: over the quote capannex-xv/chapter-ii/4.6 1 withheld: over the quote capannex-xv/chapter-iii/1 2 withheld: over the quote capannex-xv/chapter-iii/2 1 withheld: over the quote capannex-xv/chapter-iii/3 2 withheld: over the quote capannex-xv/chapter-iii/4 1 withheld: over the quote capannex-xv/chapter-iii/6 1 withheld: over the quote capannex-xv/chapter-iii/7 1 withheld: over the quote capCounts and dates over a stated window. No figure here is a mark out of a hundred, no cell is ordered against another, and none of it is a statement about the publisher: a day this record did not reach is a fact about this record’s reach.
blocked ×2. Of those, 47 produced a digest: a page that answers and is assembled in the browser answers without one. browser. What that record returned is in Observation history above.
Each format carries the permalink and the date this legal act was observed. The observation date is part of the citation: the underlying source may have changed since.
GxPlex. Regulation (EU) 2017/745 on medical devices [legal act record]. Observed 2 November 2026. https://gxplex.com/r/eu-mdr Primary source: https://eur-lex.europa.eu/eli/reg/2017/745/oj
@misc{gxplexreumdr,
author = {{GxPlex}},
title = {{Regulation (EU) 2017/745 on medical devices}},
year = {2026},
note = {legal act record, observed 2 November 2026},
howpublished = {\url{https://gxplex.com/r/eu-mdr}},
urldate = {2026-11-02},
url = {https://eur-lex.europa.eu/eli/reg/2017/745/oj}
} GxPlex. (2026). Regulation (EU) 2017/745 on medical devices [legal act record]. Retrieved 2 November 2026, from https://gxplex.com/r/eu-mdr
{
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"@type": "Dataset",
"name": "Regulation (EU) 2017/745 on medical devices",
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"temporalCoverage": "2026-11-02",
"observation": {
"url": "https://gxplex.com/observations/eu-mdr#obs-2026-11-02-1",
"observedDate": "2026-11-02"
},
"isBasedOn": "https://eur-lex.europa.eu/eli/reg/2017/745/oj"
} observation.url addresses the single observation this
citation rests on.
Every observation of this document is addressed and separately citable at the observation series.
| Entry | text_retained | licence_class | quote_allowed | snapshot_available |
|---|---|---|---|---|
| EU MDR | true | open | true | true |
| EU AI Act | true | open | true | true |
| EU Cyber Resilience Act | true | open | true | true |
| Regulation (EU) 2026/1744 | true | open | true | true |
| EU IVDR | true | open | true | true |
| EU NIS2 Directive | true | open | true | true |
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A field and some words a reader may keep beside this entry while reading it. This record never sees the note: nothing is sent anywhere, nothing is stored on this device, and it is gone when the page is reloaded. Nothing below is selected until a reader selects it — no default is offered here, and this record states no view about which of the four words belongs on this entry.
Those four words are a reader's own vocabulary, not this record's description of the document. A judgement of consequence, a decision to keep watching, a decision to look further and a decision to raise are refused in this record's own voice by the wall it publishes under, and that refusal is why the choice sits with a reader rather than being made here.
The copy control puts the note on this device's clipboard as Markdown,
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