GxPlex

EU IVDR

Regulation (EU) 2017/746 on in vitro diagnostic medical devices

Recorded status
in force (basis: person-ratified)
Last person check
— a person confirmed the status this entry publishes
Last observation
Retained text
held — Prose was extracted from the retrieved bytes, so a quotation from this document can be checked against what this record retained.

2 corrections name this row · last → history

Evidence coverage#

Of the 12 rungs of this entry’s evidence ladder: 8 held · 2 held in part · 1 read, and not there · 1 nothing held.

The 12 rungs, each with its mark
  1. identity — held
  2. publisher — held
  3. jurisdiction — held
  4. type — held
  5. current edition — held
  6. publication date — held in part
  7. lifecycle signal — nothing held
  8. publisher notices — read, and not there
  9. observation history — held
  10. text — held
  11. diff — held in part
  12. verification — 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.

What this record does not establish#

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. lifecycle signal this record has not looked a stage, step or status wording read from a publisher surface No read of a publisher surface for a stage or status wording is recorded for this entry.
  2. publisher notices this record cannot tell which official notices the publisher issued about this document A collection of publisher notices has succeeded and none of the records it holds attaches to this entry.

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:

  1. Observed cadence: how often this record has reached this entry’s address
  2. Text: public, and retained: whether the publisher’s text is public, and whether prose from it is kept here
  3. Hash: what is digested for this entry, and of what
  4. Status verification: which check this record undertakes for the published status, and which it holds
  5. Lifecycle tracked: which lifecycle facts this record follows for this entry
  6. Known limits: the limits this entry’s own record declares

Overview#

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 25 February 2022 (basis: the act named under Established by)

Verification what a person or a tool has confirmed here, and when

Publisher: European Parliament and Council Last checked: Last read:

Evidence state what this record holds

verified by a person — a person checked this entry against the primary source on a recorded day

How this status is recorded
Recorded
in force as of 25 February 2022
Established by
A person confirmed this entry on 28 July 2026.
Evidence
In Current status on this page.
Published at
This record names no separate surface for the status. The primary source it holds is the primary source (opens in new tab). This entry's record is published in machine form at /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

Authority
European Parliament and Council
Jurisdiction
EU
Status
in force
Effective date
(basis: a calendar entry citing its source (opens in new tab) eur-lex.europa.eu, date confidence confirmed; listed under Dates)
Last changed
—
Last verified
(person-ratified: a key stands on the status this entry publishes)
Watch cadence
quarterly
Crawlable
partial · renders client-side
Text licence
freely reproducible
Primary source
Primary source (opens in new tab) eur-lex.europa.eu
Topics
medical devices · in vitro diagnostic

Timeline#

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-ivdr.json. The route set naming them, and what each one answers, is published at /developers.

Dates#

Recorded dates for this instrument
DateEvent ConfidenceSource
2022-02-25 effective date
EU IVDR recorded as in force as of this date		 confirmed link (opens in new tab)

Archived versions#

Change history#

Publisher neighbourhood#

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.

The direct document, and the activity around it what this record’s observations of the document recorded inside a stated window, beside the official signals dated inside the same one
Each row is a window of calendar days ending , the day the source-health block below counts its own window to. Every column between the window and the official signals is drawn from the 193 observation(s) of the document this entry holds in total. An observation is counted here only where the class projection places it on the document this entry names.
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.

Around it official signals naming this entry, by the class their publisher stated
— 88 of the 88 record(s) the store holds could be tested against this entry, and none names it. That zero is a measurement.
Related sources other entries reachable from this one by a relation a publisher states
0 relation(s) this entry’s own publisher states, 1 citation edge(s) out of its retained text and 5 into it. They reach 5 other entry(ies) this record tracks. Each one is listed with the words that state it and the address they were read from, in the section holding it below.
Related standards which of those entries call themselves a standard, in their own publisher’s word
Of the 5 entry(ies) reached, 0 carry their publisher’s word for a consensus standard, 4 state another class and 1 state none. A related entry is counted as a standard only where that entry’s own record carries the publisher’s word for it, quoted and cited on that entry’s page. Nothing is read from a designator: a title containing the letters of a standards body is not a publisher calling a document a standard. Where an entry states no class, it is counted as stating none rather than as not being one.
Topics record identifiers for publisher-stated values, and the voice each one is in
2 identifier(s), minted by the convention published at /conventions. The values themselves are not listed again here; what this adds is the identifier and the voice it is in. 2 come(s) from a term this document’s own publisher states about it, quoted with its citation lower on this page: topic.medical-devices · topic.in-vitro-diagnostic.
Before, now and next where the record’s day sits among the publisher-dated facts this entry holds

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.

  • Before — effective date, the nearest of 1, on 2022-02-25 — recorded as confirmed
  • Now — the record’s day falls after every publisher-dated fact this entry holds.
  • Next — no publisher-dated fact this record holds falls after that day

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.

Subject and class (as stated)

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.

Citations (within the tracked corpus)

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

Cites (as published)

These citations are drawn together on the citation graph, where every row carries the same quote and source.

Cited by (within the tracked corpus)

Family (along publisher-stated edges)

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.

Shared publisher terms

No term in the index lists this entry.

Terms retired from the index that had listed this entry. Each address says which text did not hold the words.

contextual mapping — not a regulatory applicability determination The policy, stated once

Evidence#

Current status#

Recorded as in-force against the primary source on 28 July 2026.

The supporting text is not reproduced here. The banked passage is the Article 113 heading and the sentence stating when this Regulation enters into force; no span within it states that it is in force. It was retrieved 28 July 2026 by browser and is at the location below, in the primary source.

Found at: character offset 327283

Evidence ladder#

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.

The 12 rungs, as marked for this entry
  1. held. identity an address that describes this document rather than a list it sits in This record holds an address that describes this document, and the names it is published under.
  2. held. publisher the body that published it The publishing body is recorded as European Parliament and Council.
  3. held. jurisdiction the jurisdiction the publishing body belongs to The jurisdiction is recorded as EU.
  4. held. type the class the document calls itself, quoted from its own title The document’s own title states a class, quoted on this page with the address it was read from.
  5. held. current edition a statement of which edition or revision this record holds This record holds 1 archived version of this document, under the version label this record filed for it.
  6. held in part. publication date a date the publisher states for this document No publication date is recorded for this entry. What is held is 1 dated event, cited on this page; a dated event is not a publication date.
  7. nothing held. lifecycle signal a stage, step or status wording read from a publisher surface No read of a publisher surface for a stage or status wording is recorded for this entry.
  8. read, and not there. publisher notices official notices the publisher issued about this document A collection of publisher notices has succeeded and none of the records it holds attaches to this entry.
  9. held. observation history a dated series of what the publisher’s address returned This record holds 193 dated records for this entry, and every one of them is of the document it names.
  10. held. text prose retained from the retrieved bytes, against which a quotation can be checked Prose was extracted from the retrieved bytes, so a quotation from this document can be checked against what this record retained.
  11. held in part. diff a comparison of two retrievals of this document 82 retrievals of this document carry a digest, and the store records no retrieval differing from the one before it.
  12. held. verification a person’s check of this entry against the primary source A person checked this entry against the primary source; the day is recorded above.

✓ 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.

What the evidence states

  • This record holds an address that describes this document, and the names it is published under.
  • The publishing body is recorded as European Parliament and Council.
  • The jurisdiction is recorded as EU.
  • The document’s own title states a class, quoted on this page with the address it was read from.
  • This record holds 1 archived version of this document, under the version label this record filed for it.
  • This record holds 193 dated records for this entry, and every one of them is of the document it names.
  • Prose was extracted from the retrieved bytes, so a quotation from this document can be checked against what this record retained.
  • A person checked this entry against the primary source; the day is recorded above.

What it does not state

  • No publication date is recorded for this entry. What is held is 1 dated event, cited on this page; a dated event is not a publication date.
  • No read of a publisher surface for a stage or status wording is recorded for this entry.
  • A collection of publisher notices has succeeded and none of the records it holds attaches to this entry.
  • 82 retrievals of this document carry a digest, and the store records no retrieval differing from the one before it.

Evidence states#

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.

  1. not a document not met a body, committee or programme — there is no document here to retrieve, quote or date The object model records this entry’s own type as document.
  2. a register not met retrieved and hashed daily; the tier promises no person-verification The record tier this entry declares is core and its freeze reason is not recorded.
  3. unstated by the publisher not met a surface was read and it states no status term this publisher’s family declares; bounded to the surfaces read This entry carries no status basis and no recorded tool reading that found none, and no status read on file for it reports a surface that states none.
  4. verified by a person (person-ratified) carried a person checked this entry against the primary source on a recorded day This entry records the check as made by a person: checked_by reads human.
  5. source access limited not met the publisher’s licence or its access policy limits what this record takes from the source The freeze reason this entry declares is not recorded, its licence class is open, and its record of whether the publisher excludes automated clients reads false.
  6. publisher metadata not met what is held is metadata the publisher publishes about the document — a catalogue entry or a stage record — not the document The resolution strategy this entry declares is direct_document, what its address points at is declared as document, and no stage the publisher publishes is held for it.
  7. observed also true the document at the address the publisher answered is retrieved and hashed here on a dated series This record holds 82 dated retrievals of the document this entry names, each carrying a digest.
  8. not currently retrievable not met no retrieval of the document this entry names has produced a digest 82 dated retrievals of the document this entry names have produced a digest here.

◆ 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

Coverage contract#

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.

Observed cadence how often this record has reached this entry’s address
Every interval between consecutive days holding an observation is 1 day. The term this record declares for the entry is “quarterly”.
Text: public, and retained whether the publisher’s text is public, and whether prose from it is kept here
The publisher’s text is freely reproducible. Prose is retained from the retrieved bytes, so a quotation can be checked against it.
Hash what is digested for this entry, and of what
82 of 193 record(s) classified as being of the document this entry names carry a digest of the retrieved bytes.
Status verification which check this record undertakes for the published status, and which it holds
This entry’s label undertakes to close an open status question by rule on a clock, with its reason, and to re-read a ratification on record against its observation every night. A person’s confirmation is recorded, dated 2026-07-28.
Lifecycle tracked which lifecycle facts this record follows for this entry
This record follows 1 dated event(s) · 1 archived version(s) for this entry. 36 of 132 tracked entries carry at least one such fact.
Known limits the limits this entry’s own record declares
1 of the 8 limits this record can record is set on this entry, and each is listed below with the field it was read from.

Why this entry is tracked#

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.

Inclusion-rule limb which of the four limbs was applied
— No field in this record names which limb an entry satisfies, so none is stated for this one. Membership was closed as a human judgment on 2026-08-11, and the four-limb test is applied by a person rather than by code. This entry’s own stated subject is not read as a limb: a title word standing in for a rule would be a classification this record authored.
Admission entry the dated act that added this entry
— No admission entry is recorded for this entry. 21 of 132 tracked entries carry one, so an absence here is ordinary rather than a gap peculiar to this entry.
Declared tier-1 list a recorded judgement that this belongs
This entry is not a member of the declared tier-1 list. That list names 37 identifiers, of which 35 resolve to one of the 132 tracked entries, so most of the corpus sits outside it and non-membership says nothing about this entry on its own.
Admissions boundary the jurisdictions this record adds from
This entry’s jurisdiction is EU. It is inside the admissions boundary ruled on 2026-08-16, which names 4 jurisdictions — EU · US · UK · International — and which is one of the two admission tests this record enforces in code. The other is that a candidate carry the publisher’s own address: a mention is not a citation.

Observation history#

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-ivdr. Any two of its retained observations can be set side by side at /compare/eu-ivdr. The same evidence as a packet, with its refusals and its integrity reference, is at /packet/eu-ivdr.

Every observation in this series is published, untruncated, at /api/v1/observations.json.

Of the retrievals classified as this document: same digest on 31 observed days, 2026-07-28 to 2026-10-18 (82 retrievals); 52 of the 83 calendar days in that span hold no digest of this document and are not counted; no earlier digest of this document is recorded; 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.

First observed
2026-07-28
Last observed
2026-11-02 (HTTP 202)
Fetch method
browser
Current hash
—
How this series is recorded
Recorded
observations: 193 · carrying a digest: 82 · marked ! (digest differed): 0 · first observed: 2026-07-28
Method
resolution: direct document · watch cadence: quarterly · last fetch method: browser
Evidence
The most recent record is addressed at 2026-11-02·1.
Published at
/observations/eu-ivdr — 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.

Clauses, definitions and sentences (as printed)#

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.

Text 903e40aaebe6 (current text), first observed 2026-07-28

Clause anchors: read; 907 placed and 0 withheld.

  • chapter-i CHAPTER I
  • chapter-i/section-1 Section 1
  • chapter-i/section-1/article-1 Article 1
  • chapter-i/section-1/article-1/1 1.
  • chapter-i/section-1/article-1/2 2.
  • chapter-i/section-1/article-1/3 3.
  • chapter-i/section-1/article-1/4 4.
  • chapter-i/section-1/article-1/5 5.
  • chapter-i/section-1/article-1/6 6.
  • chapter-i/section-1/article-1/7 7.
  • chapter-i/section-1/article-1/8 8.
  • chapter-i/section-1/article-1/9 9.
  • chapter-i/section-1/article-1/10 10.
  • chapter-i/section-1/article-2 Article 2
  • chapter-i/section-2 Section 2
  • chapter-i/section-2/article-3 Article 3
  • chapter-i/section-2/article-3/1 1.
  • chapter-i/section-2/article-3/2 2.
  • chapter-i/section-2/article-3/3 3.
  • chapter-i/section-2/article-3/4 4.
  • chapter-i/section-2/article-4 Article 4
  • chapter-i/section-2/article-4/1 1.
  • chapter-i/section-2/article-4/2 2.
  • chapter-i/section-2/article-4/3 3.
  • chapter-i/section-2/article-4/4 4.
  • chapter-ii CHAPTER II
  • chapter-ii/article-5 Article 5
  • chapter-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 6
  • chapter-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 7
  • chapter-ii/article-8 Article 8
  • chapter-ii/article-8/1 1.
  • chapter-ii/article-8/2 2.
  • chapter-ii/article-9 Article 9
  • chapter-ii/article-9/1 1.
  • chapter-ii/article-9/2 2.
  • chapter-ii/article-9/3 3.
  • chapter-ii/article-10 Article 10
  • chapter-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-11 Article 11
  • chapter-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 12
  • chapter-ii/article-13 Article 13
  • chapter-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 14
  • chapter-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 15
  • chapter-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 16
  • chapter-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 17
  • chapter-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-18 Article 18
  • chapter-ii/article-18/1 1.
  • chapter-ii/article-18/2 2.
  • chapter-ii/article-18/3 3.
  • chapter-ii/article-18/4 4.
  • chapter-ii/article-18/5 5.
  • chapter-ii/article-18/6 6.
  • chapter-ii/article-19 Article 19
  • chapter-ii/article-19/1 1.
  • chapter-ii/article-19/2 2.
  • chapter-ii/article-19/3 3.
  • chapter-ii/article-20 Article 20
  • chapter-ii/article-20/1 1.
  • chapter-ii/article-20/2 2.
  • chapter-ii/article-21 Article 21
  • chapter-iii CHAPTER III
  • chapter-iii/article-22 Article 22
  • chapter-iii/article-22/1 1.
  • chapter-iii/article-22/2 2.
  • chapter-iii/article-23 Article 23
  • chapter-iii/article-24 Article 24
  • chapter-iii/article-24/1 1.
  • chapter-iii/article-24/2 2.
  • chapter-iii/article-24/3 3.
  • chapter-iii/article-24/4 4.
  • chapter-iii/article-24/5 5.
  • chapter-iii/article-24/6 6.
  • chapter-iii/article-24/7 7.
  • chapter-iii/article-24/8 8.
  • chapter-iii/article-24/9 9.
  • chapter-iii/article-24/10 10.
  • chapter-iii/article-24/11 11.
  • chapter-iii/article-24/12 12.
  • chapter-iii/article-25 Article 25
  • chapter-iii/article-26 Article 26
  • chapter-iii/article-26/1 1.
  • chapter-iii/article-26/2 2.
  • chapter-iii/article-26/3 3.
  • chapter-iii/article-27 Article 27
  • chapter-iii/article-27/1 1.
  • chapter-iii/article-27/2 2.
  • chapter-iii/article-27/3 3.
  • chapter-iii/article-28 Article 28
  • chapter-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-28/5 5.
  • chapter-iii/article-28/6 6.
  • chapter-iii/article-28/7 7.
  • chapter-iii/article-28/8 8.
  • chapter-iii/article-29 Article 29
  • chapter-iii/article-29/1 1.
  • chapter-iii/article-29/2 2.
  • chapter-iii/article-29/3 3.
  • chapter-iii/article-30 Article 30
  • chapter-iii/article-30/1 1.
  • chapter-iii/article-30/2 2.
  • chapter-iv CHAPTER IV
  • chapter-iv/article-31 Article 31
  • chapter-iv/article-31/1 1.
  • chapter-iv/article-31/2 2.
  • chapter-iv/article-31/3 3.
  • chapter-iv/article-31/4 4.
  • chapter-iv/article-31/5 5.
  • chapter-iv/article-31/6 6.
  • chapter-iv/article-31/7 7.
  • chapter-iv/article-31/8 8.
  • chapter-iv/article-32 Article 32
  • chapter-iv/article-32/1 1.
  • chapter-iv/article-32/2 2.
  • chapter-iv/article-32/3 3.
  • chapter-iv/article-33 Article 33
  • chapter-iv/article-33/1 1.
  • chapter-iv/article-33/2 2.
  • chapter-iv/article-33/3 3.
  • chapter-iv/article-33/4 4.
  • chapter-iv/article-33/5 5.
  • chapter-iv/article-34 Article 34
  • chapter-iv/article-34/1 1.
  • chapter-iv/article-34/2 2.
  • chapter-iv/article-34/3 3.
  • chapter-iv/article-35 Article 35
  • chapter-iv/article-35/1 1.
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  • 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-35/9 9.
  • chapter-iv/article-35/10 10.
  • chapter-iv/article-36 Article 36
  • chapter-iv/article-36/1 1.
  • chapter-iv/article-36/2 2.
  • chapter-iv/article-37 Article 37
  • chapter-iv/article-38 Article 38
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  • chapter-iv/article-38/8 8.
  • chapter-iv/article-38/9 9.
  • chapter-iv/article-38/10 10.
  • chapter-iv/article-38/11 11.
  • chapter-iv/article-38/12 12.
  • chapter-iv/article-39 Article 39
  • chapter-iv/article-39/1 1.
  • chapter-iv/article-39/2 2.
  • chapter-iv/article-40 Article 40
  • chapter-iv/article-40/1 1.
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  • chapter-iv/article-40/6 6.
  • chapter-iv/article-40/7 7.
  • chapter-iv/article-40/8 8.
  • chapter-iv/article-40/9 9.
  • chapter-iv/article-40/10 10.
  • chapter-iv/article-40/11 11.
  • chapter-iv/article-40/12 12.
  • chapter-iv/article-41 Article 41
  • chapter-iv/article-41/1 1.
  • chapter-iv/article-41/2 2.
  • chapter-iv/article-41/3 3.
  • chapter-iv/article-41/4 4.
  • chapter-iv/article-41/5 5.
  • chapter-iv/article-41/6 6.
  • chapter-iv/article-42 Article 42
  • chapter-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-43 Article 43
  • chapter-iv/article-43/1 1.
  • chapter-iv/article-43/2 2.
  • chapter-iv/article-43/3 3.
  • chapter-iv/article-43/4 4.
  • chapter-iv/article-43/5 5.
  • chapter-iv/article-44 Article 44
  • chapter-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-45 Article 45
  • chapter-iv/article-46 Article 46
  • chapter-v CHAPTER V
  • chapter-v/section-1 Section 1
  • chapter-v/section-1/article-47 Article 47
  • chapter-v/section-1/article-47/1 1.
  • chapter-v/section-1/article-47/2 2.
  • chapter-v/section-1/article-47/3 3.
  • chapter-v/section-1/article-47/4 4.
  • chapter-v/section-1/article-47/5 5.
  • chapter-v/section-1/article-47/6 6.
  • chapter-v/section-2 Section 2
  • chapter-v/section-2/article-48 Article 48
  • chapter-v/section-2/article-48/1 1.
  • chapter-v/section-2/article-48/2 2.
  • chapter-v/section-2/article-48/3 3.
  • chapter-v/section-2/article-48/4 4.
  • chapter-v/section-2/article-48/5 5.
  • chapter-v/section-2/article-48/6 6.
  • chapter-v/section-2/article-48/7 7.
  • chapter-v/section-2/article-48/8 8.
  • chapter-v/section-2/article-48/9 9.
  • chapter-v/section-2/article-48/10 10.
  • chapter-v/section-2/article-48/11 11.
  • chapter-v/section-2/article-48/12 12.
  • chapter-v/section-2/article-48/13 13.
  • chapter-v/section-2/article-49 Article 49
  • chapter-v/section-2/article-49/1 1.
  • chapter-v/section-2/article-49/2 2.
  • chapter-v/section-2/article-49/3 3.
  • chapter-v/section-2/article-49/4 4.
  • chapter-v/section-2/article-49/5 5.
  • chapter-v/section-2/article-50 Article 50
  • chapter-v/section-2/article-50/1 1.
  • chapter-v/section-2/article-50/2 2.
  • chapter-v/section-2/article-50/3 3.
  • chapter-v/section-2/article-51 Article 51
  • chapter-v/section-2/article-51/1 1.
  • chapter-v/section-2/article-51/2 2.
  • chapter-v/section-2/article-51/3 3.
  • chapter-v/section-2/article-51/4 4.
  • chapter-v/section-2/article-51/5 5.
  • chapter-v/section-2/article-51/6 6.
  • chapter-v/section-2/article-52 Article 52
  • chapter-v/section-2/article-53 Article 53
  • chapter-v/section-2/article-53/1 1.
  • chapter-v/section-2/article-53/2 2.
  • chapter-v/section-2/article-54 Article 54
  • chapter-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-55 Article 55
  • chapter-v/section-2/article-55/1 1.
  • chapter-v/section-2/article-55/2 2.
  • chapter-vi CHAPTER VI
  • chapter-vi/article-56 Article 56
  • chapter-vi/article-56/1 1.
  • chapter-vi/article-56/2 2.
  • chapter-vi/article-56/3 3.
  • chapter-vi/article-56/4 4.
  • chapter-vi/article-56/5 5.
  • chapter-vi/article-56/6 6.
  • chapter-vi/article-56/7 7.
  • chapter-vi/article-57 Article 57
  • chapter-vi/article-57/1 1.
  • chapter-vi/article-57/2 2.
  • chapter-vi/article-57/3 3.
  • chapter-vi/article-58 Article 58
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  • chapter-vi/article-58/4 4.
  • chapter-vi/article-58/5 5.
  • chapter-vi/article-58/6 6.
  • chapter-vi/article-58/7 7.
  • chapter-vi/article-58/8 8.
  • chapter-vi/article-59 Article 59
  • chapter-vi/article-59/1 1.
  • chapter-vi/article-59/2 2.
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  • chapter-vi/article-59/4 4.
  • chapter-vi/article-59/5 5.
  • chapter-vi/article-59/6 6.
  • chapter-vi/article-59/7 7.
  • chapter-vi/article-60 Article 60
  • chapter-vi/article-60/1 1.
  • chapter-vi/article-60/2 2.
  • chapter-vi/article-60/3 3.
  • chapter-vi/article-61 Article 61
  • chapter-vi/article-61/1 1.
  • chapter-vi/article-61/2 2.
  • chapter-vi/article-62 Article 62
  • chapter-vi/article-63 Article 63
  • chapter-vi/article-64 Article 64
  • chapter-vi/article-64/1 1.
  • chapter-vi/article-64/2 2.
  • chapter-vi/article-64/3 3.
  • chapter-vi/article-65 Article 65
  • chapter-vi/article-65/1 1.
  • chapter-vi/article-65/2 2.
  • chapter-vi/article-66 Article 66
  • chapter-vi/article-66/1 1.
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  • chapter-vi/article-66/6 6.
  • chapter-vi/article-66/7 7.
  • chapter-vi/article-66/8 8.
  • chapter-vi/article-66/9 9.
  • chapter-vi/article-67 Article 67
  • chapter-vi/article-67/1 1.
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  • chapter-vi/article-67/4 4.
  • chapter-vi/article-68 Article 68
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  • chapter-vi/article-68/5 5.
  • chapter-vi/article-68/6 6.
  • chapter-vi/article-69 Article 69
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  • chapter-vi/article-69/5 5.
  • chapter-vi/article-70 Article 70
  • chapter-vi/article-70/1 1.
  • chapter-vi/article-70/2 2.
  • chapter-vi/article-71 Article 71
  • chapter-vi/article-71/1 1.
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  • chapter-vi/article-71/4 4.
  • chapter-vi/article-72 Article 72
  • chapter-vi/article-72/1 1.
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  • chapter-vi/article-72/4 4.
  • chapter-vi/article-73 Article 73
  • chapter-vi/article-73/1 1.
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  • chapter-vi/article-73/4 4.
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  • chapter-vi/article-73/6 6.
  • chapter-vi/article-73/7 7.
  • chapter-vi/article-74 Article 74
  • chapter-vi/article-74/1 1.
  • chapter-vi/article-74/2 2.
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  • chapter-vi/article-74/4 4.
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  • chapter-vi/article-74/6 6.
  • chapter-vi/article-74/7 7.
  • chapter-vi/article-74/8 8.
  • chapter-vi/article-74/9 9.
  • chapter-vi/article-74/10 10.
  • chapter-vi/article-74/11 11.
  • chapter-vi/article-74/12 12.
  • chapter-vi/article-74/13 13.
  • chapter-vi/article-74/14 14.
  • chapter-vi/article-75 Article 75
  • chapter-vi/article-76 Article 76
  • chapter-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-76/5 5.
  • chapter-vi/article-76/6 6.
  • chapter-vi/article-77 Article 77
  • chapter-vii CHAPTER VII
  • chapter-vii/section-1 Section 1
  • chapter-vii/section-1/article-78 Article 78
  • chapter-vii/section-1/article-78/1 1.
  • chapter-vii/section-1/article-78/2 2.
  • chapter-vii/section-1/article-78/3 3.
  • chapter-vii/section-1/article-78/4 4.
  • chapter-vii/section-1/article-79 Article 79
  • chapter-vii/section-1/article-80 Article 80
  • chapter-vii/section-1/article-81 Article 81
  • chapter-vii/section-1/article-81/1 1.
  • chapter-vii/section-1/article-81/2 2.
  • chapter-vii/section-1/article-81/3 3.
  • chapter-vii/section-2 Section 2
  • chapter-vii/section-2/article-82 Article 82
  • chapter-vii/section-2/article-82/1 1.
  • chapter-vii/section-2/article-82/2 2.
  • chapter-vii/section-2/article-82/3 3.
  • chapter-vii/section-2/article-82/4 4.
  • chapter-vii/section-2/article-82/5 5.
  • chapter-vii/section-2/article-82/6 6.
  • chapter-vii/section-2/article-82/7 7.
  • chapter-vii/section-2/article-82/8 8.
  • chapter-vii/section-2/article-82/9 9.
  • chapter-vii/section-2/article-82/10 10.
  • chapter-vii/section-2/article-82/11 11.
  • chapter-vii/section-2/article-83 Article 83
  • chapter-vii/section-2/article-83/1 1.
  • chapter-vii/section-2/article-83/2 2.
  • chapter-vii/section-2/article-84 Article 84
  • chapter-vii/section-2/article-84/1 1.
  • chapter-vii/section-2/article-84/2 2.
  • chapter-vii/section-2/article-84/3 3.
  • chapter-vii/section-2/article-84/4 4.
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  • chapter-vii/section-2/article-84/6 6.
  • chapter-vii/section-2/article-84/7 7.
  • chapter-vii/section-2/article-84/8 8.
  • chapter-vii/section-2/article-84/9 9.
  • chapter-vii/section-2/article-84/10 10.
  • chapter-vii/section-2/article-84/11 11.
  • chapter-vii/section-2/article-85 Article 85
  • chapter-vii/section-2/article-86 Article 86
  • chapter-vii/section-2/article-87 Article 87
  • chapter-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-3 Section 3
  • chapter-vii/section-3/article-88 Article 88
  • chapter-vii/section-3/article-88/1 1.
  • chapter-vii/section-3/article-88/2 2.
  • chapter-vii/section-3/article-88/3 3.
  • chapter-vii/section-3/article-88/4 4.
  • chapter-vii/section-3/article-88/5 5.
  • chapter-vii/section-3/article-88/6 6.
  • chapter-vii/section-3/article-88/7 7.
  • chapter-vii/section-3/article-88/8 8.
  • chapter-vii/section-3/article-88/9 9.
  • chapter-vii/section-3/article-88/10 10.
  • chapter-vii/section-3/article-88/11 11.
  • chapter-vii/section-3/article-89 Article 89
  • chapter-vii/section-3/article-90 Article 90
  • chapter-vii/section-3/article-90/1 1.
  • chapter-vii/section-3/article-90/2 2.
  • chapter-vii/section-3/article-90/3 3.
  • chapter-vii/section-3/article-90/4 4.
  • chapter-vii/section-3/article-90/5 5.
  • chapter-vii/section-3/article-90/6 6.
  • chapter-vii/section-3/article-90/7 7.
  • chapter-vii/section-3/article-91 Article 91
  • chapter-vii/section-3/article-91/1 1.
  • chapter-vii/section-3/article-91/2 2.
  • chapter-vii/section-3/article-91/3 3.
  • chapter-vii/section-3/article-92 Article 92
  • chapter-vii/section-3/article-92/1 1.
  • chapter-vii/section-3/article-92/2 2.
  • chapter-vii/section-3/article-92/3 3.
  • chapter-vii/section-3/article-93 Article 93
  • chapter-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-94 Article 94
  • chapter-vii/section-3/article-94/1 1.
  • chapter-vii/section-3/article-94/2 2.
  • chapter-vii/section-3/article-94/3 3.
  • chapter-vii/section-3/article-94/4 4.
  • chapter-vii/section-3/article-95 Article 95
  • chapter-vii/section-3/article-95/1 1.
  • chapter-vii/section-3/article-95/2 2.
  • chapter-vii/section-3/article-95/3 3.
  • chapter-viii CHAPTER VIII
  • chapter-viii/article-96 Article 96
  • chapter-viii/article-97 Article 97
  • chapter-viii/article-97/1 1.
  • chapter-viii/article-97/2 2.
  • chapter-viii/article-98 Article 98
  • chapter-viii/article-99 Article 99
  • chapter-viii/article-100 Article 100
  • chapter-viii/article-100/1 1.
  • chapter-viii/article-100/2 2.
  • chapter-viii/article-100/3 3.
  • chapter-viii/article-100/4 4.
  • chapter-viii/article-100/5 5.
  • chapter-viii/article-100/6 6.
  • chapter-viii/article-100/7 7.
  • chapter-viii/article-100/8 8.
  • chapter-viii/article-100/9 9.
  • chapter-viii/article-100/10 10.
  • chapter-viii/article-101 Article 101
  • chapter-ix CHAPTER IX
  • chapter-ix/article-102 Article 102
  • chapter-ix/article-102/1 1.
  • chapter-ix/article-102/2 2.
  • chapter-ix/article-102/3 3.
  • chapter-ix/article-102/4 4.
  • chapter-ix/article-103 Article 103
  • chapter-ix/article-103/1 1.
  • chapter-ix/article-103/2 2.
  • chapter-ix/article-104 Article 104
  • chapter-ix/article-104/1 1.
  • chapter-ix/article-104/2 2.
  • chapter-ix/article-105 Article 105
  • chapter-ix/article-106 Article 106
  • chapter-x CHAPTER X
  • chapter-x/article-107 Article 107
  • chapter-x/article-107/1 1.
  • chapter-x/article-107/2 2.
  • chapter-x/article-107/3 3.
  • chapter-x/article-107/4 4.
  • chapter-x/article-108 Article 108
  • chapter-x/article-108/1 1.
  • chapter-x/article-108/2 2.
  • chapter-x/article-108/3 3.
  • chapter-x/article-108/4 4.
  • chapter-x/article-108/5 5.
  • chapter-x/article-108/6 6.
  • chapter-x/article-109 Article 109
  • chapter-x/article-110 Article 110
  • chapter-x/article-110/1 1.
  • chapter-x/article-110/2 2.
  • chapter-x/article-110/3 3.
  • chapter-x/article-110/4 4.
  • chapter-x/article-110/5 5.
  • chapter-x/article-110/6 6.
  • chapter-x/article-110/7 7.
  • chapter-x/article-110/8 8.
  • chapter-x/article-110/9 9.
  • chapter-x/article-110/10 10.
  • chapter-x/article-111 Article 111
  • chapter-x/article-112 Article 112
  • chapter-x/article-113 Article 113
  • chapter-x/article-113/1 1.
  • chapter-x/article-113/2 2.
  • chapter-x/article-113/3 3.
  • annex-i ANNEX I
  • annex-i/chapter-i CHAPTER I
  • annex-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-ii CHAPTER II
  • annex-i/chapter-iii CHAPTER III
  • annex-ii ANNEX II
  • annex-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/3.1 3.1.
  • annex-ii/3.2 3.2.
  • annex-ii/4 4.
  • annex-ii/5 5.
  • annex-ii/6 6.
  • annex-ii/6.1 6.1.
  • annex-ii/6.1.1 6.1.1.
  • annex-ii/6.1.2 6.1.2.
  • annex-ii/6.1.2.1 6.1.2.1.
  • annex-ii/6.1.2.2 6.1.2.2.
  • annex-ii/6.1.2.3 6.1.2.3.
  • annex-ii/6.1.2.4 6.1.2.4.
  • annex-ii/6.1.2.5 6.1.2.5.
  • annex-ii/6.1.2.6 6.1.2.6.
  • annex-ii/6.1.3 6.1.3.
  • annex-ii/6.2 6.2.
  • annex-ii/6.3 6.3.
  • annex-ii/6.3.1 6.3.1.
  • annex-ii/6.3.2 6.3.2.
  • annex-ii/6.3.3 6.3.3.
  • annex-ii/6.4 6.4.
  • annex-ii/6.5 6.5.
  • annex-iii ANNEX III
  • annex-iii/1 1.
  • annex-iii/2 2.
  • annex-iv ANNEX IV
  • annex-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 V
  • annex-v/1 1.
  • annex-v/2 2.
  • annex-v/3 3.
  • annex-vi ANNEX VI
  • annex-vi/part-a PART A
  • annex-vi/part-a/1 1.
  • annex-vi/part-a/2 2.
  • annex-vi/part-a/2.1 2.1.
  • annex-vi/part-b PART B
  • annex-vi/part-c PART C
  • annex-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/6.2 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/6.2.3 6.2.3.
  • annex-vi/part-c/6.2.4 6.2.4.
  • annex-vii ANNEX VII
  • annex-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/4.6 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 VIII
  • annex-viii/1 1.
  • annex-viii/1.1 1.1.
  • annex-viii/1.2 1.2.
  • annex-viii/1.3 1.3.
  • annex-viii/1.4 1.4.
  • annex-viii/1.5 1.5.
  • annex-viii/1.6 1.6.
  • annex-viii/1.7 1.7.
  • annex-viii/1.8 1.8.
  • annex-viii/1.9 1.9.
  • annex-viii/1.10 1.10.
  • annex-viii/2 2.
  • annex-viii/2.1 2.1.
  • annex-viii/2.2 2.2.
  • annex-viii/2.3 2.3.
  • annex-viii/2.4 2.4.
  • annex-viii/2.5 2.5.
  • annex-viii/2.6 2.6.
  • annex-viii/2.7 2.7.
  • annex-ix ANNEX IX
  • annex-ix/chapter-i CHAPTER I
  • annex-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 II
  • annex-ix/chapter-iii CHAPTER III
  • annex-x ANNEX X
  • annex-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/5.4 5.4.
  • annex-x/5.5 5.5.
  • annex-x/6 6.
  • annex-xi ANNEX XI
  • annex-xi/1 1.
  • annex-xi/2 2.
  • annex-xi/3 3.
  • annex-xi/3.1 3.1.
  • annex-xi/3.2 3.2.
  • annex-xi/3.3 3.3.
  • annex-xi/3.4 3.4.
  • annex-xi/4 4.
  • annex-xi/5 5.
  • annex-xi/5.1 5.1.
  • annex-xi/5.2 5.2.
  • annex-xi/6 6.
  • annex-xii ANNEX XII
  • annex-xii/chapter-i CHAPTER I
  • annex-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 II
  • annex-xiii ANNEX XIII
  • annex-xiii/part-a PART A
  • annex-xiii/part-a/1 1.
  • annex-xiii/part-a/1.1 1.1.
  • annex-xiii/part-a/1.2 1.2.
  • annex-xiii/part-a/1.2.1 1.2.1.
  • annex-xiii/part-a/1.2.2 1.2.2.
  • annex-xiii/part-a/1.2.3 1.2.3.
  • annex-xiii/part-a/1.3 1.3.
  • annex-xiii/part-a/1.3.1 1.3.1.
  • annex-xiii/part-a/1.3.2 1.3.2.
  • annex-xiii/part-a/1.3.3 1.3.3.
  • annex-xiii/part-a/2 2.
  • annex-xiii/part-a/2.1 2.1.
  • annex-xiii/part-a/2.2 2.2.
  • annex-xiii/part-a/2.3 2.3.
  • annex-xiii/part-a/2.3.1 2.3.1.
  • annex-xiii/part-a/2.3.2 2.3.2.
  • annex-xiii/part-a/2.3.3 2.3.3.
  • annex-xiii/part-a/3 3.
  • annex-xiii/part-b PART B
  • annex-xiv ANNEX XIV
  • annex-xiv/chapter-i CHAPTER I
  • annex-xiv/chapter-i/1 1.
  • annex-xiv/chapter-i/2 2.
  • annex-xiv/chapter-i/2.1 2.1.
  • annex-xiv/chapter-i/2.2 2.2.
  • annex-xiv/chapter-i/2.3 2.3.
  • annex-xiv/chapter-i/2.4 2.4.
  • annex-xiv/chapter-i/2.5 2.5.
  • annex-xiv/chapter-i/2.6 2.6.
  • annex-xiv/chapter-i/2.7 2.7.
  • annex-xiv/chapter-i/2.8 2.8.
  • annex-xiv/chapter-i/3 3.
  • annex-xiv/chapter-i/4 4.
  • annex-xiv/chapter-i/4.1 4.1.
  • annex-xiv/chapter-i/4.2 4.2.
  • annex-xiv/chapter-i/4.3 4.3.
  • annex-xiv/chapter-i/4.4 4.4.
  • annex-xiv/chapter-i/4.5 4.5
  • annex-xiv/chapter-i/4.6 4.6.
  • annex-xiv/chapter-ii CHAPTER II
  • annex-xiv/chapter-ii/1 1.
  • annex-xiv/chapter-ii/2 2.
  • annex-xiv/chapter-ii/3 3.
  • annex-xiv/chapter-ii/4 4.
  • annex-xiv/chapter-ii/5 5.
  • annex-xv ANNEX XV

Definitions: 73 read in this text, 4 with the text quoted and 69 with the text withheld.

  • (1) medical device under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 17 words)
  • (2) in vitro diagnostic medical device under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 138 words)
  • (3) specimen receptacle under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 37 words)
  • (4) accessory for an in vitro diagnostic medical device under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 81 words)
  • (5) device for self-testing under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 32 words)
  • (6) device for near-patient testing under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 37 words)
  • (7) companion diagnostic under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 66 words)
  • (8) generic device group under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 33 words)
  • (9) single-use device under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 15 words)
  • (10) falsified device under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 45 words)
  • (11) kit under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 27 words)
  • (12) intended purpose under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 45 words)
  • (13) label under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 28 words)
  • (14) instructions for use under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 29 words)
  • (15) Unique Device Identifier under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 34 words)
  • (15) UDI under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 34 words)
  • (16) risk under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 17 words)
  • (17) benefit-risk determination under chapter-i/section-1/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)
  • (20) making available on the market under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 43 words)
  • (21) placing on the market under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 23 words)
  • (22) putting into service under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 42 words)
  • (23) manufacturer under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 33 words)
  • (24) fully refurbishing under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 56 words)
  • (25) authorised representative under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 47 words)
  • (26) importer under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 23 words)
  • (27) distributor under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 34 words)
  • (28) economic operator under chapter-i/section-1/article-2: a manufacturer, an authorised representative, an importer or a distributor;
  • (29) health institution under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 23 words)
  • (30) user under chapter-i/section-1/article-2: any healthcare professional or lay person who uses a device;
  • (31) lay person under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 20 words)
  • (32) conformity assessment under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 19 words)
  • (33) conformity assessment body under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 18 words)
  • (34) notified body under chapter-i/section-1/article-2: a conformity assessment body designated in accordance with this Regulation;
  • (35) CE marking of conformity under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 40 words)
  • (35) CE marking under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 40 words)
  • (36) clinical evidence under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 43 words)
  • (37) clinical benefit under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 36 words)
  • (38) scientific validity of an analyte under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 19 words)
  • (39) performance of a device under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 35 words)
  • (40) analytical performance under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 16 words)
  • (41) clinical performance under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 36 words)
  • (42) performance study under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 18 words)
  • (43) performance study plan under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 23 words)
  • (44) performance evaluation under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 27 words)
  • (45) device for performance study under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 42 words)
  • (46) interventional clinical performance study under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 25 words)
  • (47) subject under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 31 words)
  • (48) investigator under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 17 words)
  • (49) diagnostic specificity under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 23 words)
  • (50) diagnostic sensitivity under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 23 words)
  • (51) predictive value under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 36 words)
  • (52) positive predictive value under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 26 words)
  • (53) negative predictive value under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 26 words)
  • (54) likelihood ratio under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 40 words)
  • (55) calibrator under chapter-i/section-1/article-2: a measurement reference material used in the calibration of a device;
  • (56) control material under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 23 words)
  • (57) sponsor under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 27 words)
  • (58) informed consent under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 67 words)
  • (59) ethics committee under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 44 words)
  • (60) adverse event under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 48 words)
  • (61) serious adverse event under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 131 words)
  • (62) device deficiency under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 32 words)
  • (63) post-market surveillance under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 64 words)
  • (64) market surveillance under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 45 words)
  • (65) recall under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 22 words)
  • (66) withdrawal under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 21 words)
  • (67) incident under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 63 words)
  • (68) serious incident under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 54 words)
  • (69) serious public health threat under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 54 words)
  • (70) corrective action under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 19 words)
  • (71) field safety corrective action under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 36 words)
  • (72) field safety notice under chapter-i/section-1/article-2: text withheld (over the cap: its term and text are 22 words)
  • (73) harmonised standard under chapter-i/section-1/article-2: text withheld (end not delimited: no definition is read after it in this text)

Sentences printing a listed verb: 1536 read in this text, 119 quoted and 1417 withheld.

  • (no clause anchor before this sentence) The tasks of an authorised representative should be defined in a written mandate.
  • (no clause anchor before this sentence) It should also help to reduce medical errors and to fight against falsified devices.
  • (no clause anchor before this sentence) During this transitional period, certain provisions of Directive 98/79/EC should remain in force.
  • chapter-i/section-1/article-1/7 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 28.
  • chapter-ii/article-17/1 The manufacturer shall continuously update the EU declaration of conformity.
  • chapter-ii/article-18/4 The CE marking shall be affixed before the device is placed on the market.
  • chapter-ii/article-20/1 Supporting evidence shall be kept available for the competent authorities of the Member States.
  • chapter-iii/article-24/4 Higher levels of packaging shall not be understood to include shipping containers.
  • chapter-iii/article-27/3 Importers shall add their details to the relevant entry/entries.
  • chapter-iii/article-29/1 After its validation, the notified body shall upload the summary to Eudamed.
  • chapter-iv/article-32/1 In particular, notified bodies shall comply with Annex VII.
  • chapter-iv/article-33/3 Notified bodies shall make publicly available a list of their subsidiaries.
  • chapter-iv/article-35/1 Once the application is complete that national authority shall send it to the Commission.
  • chapter-iv/article-38/11 The designation shall become valid the day after the notification is published in NANDO.
  • chapter-iv/article-39/2 The Commission shall ensure that the list is kept up to date.
  • chapter-iv/article-41/3 Such reviews shall be conducted utilising CS.
  • chapter-iv/article-41/4 The reviews shall be conducted utilising appropriate expertise.
  • chapter-iv/article-42/2 The Commission shall immediately publish the amended notification in NANDO.
  • chapter-iv/article-43/3 The reporting and outcome of that assessment shall follow the principles of Article 35.
  • chapter-iv/article-45 The bodies notified under this Regulation shall participate in the work of that group.
  • chapter-v/section-1/article-47/1 Classification shall be carried out in accordance with Annex VIII.
  • chapter-v/section-1/article-47/2 The decision shall be made available upon request.
  • chapter-v/section-2/article-51/1 The minimum content of the certificates shall be as set out in Annex XII.
  • chapter-v/section-2/article-51/4 The notified body shall give the reasons for its decision.
  • chapter-v/section-2/article-51/5 Such information shall be accessible to the public.
  • chapter-vi/article-58/2 Such studies shall however be notified to the competent authority.
  • chapter-vi/article-58/3 Performance studies shall be subject to scientific and ethical review.
  • chapter-vi/article-59/2 In that case, the witness shall sign and date the informed consent document.
  • chapter-vi/article-59/2 The informed consent shall be documented.
  • chapter-vi/article-60/2 The subject shall as far as possible take part in the informed consent procedure.
  • chapter-vi/article-69/4 No personal data of subjects shall be publicly available.
  • chapter-vi/article-71/1 Changes to the relevant documentation shall be clearly identifiable.
  • chapter-vi/article-72/2 That opinion shall be delivered within seven days.
  • chapter-vi/article-74/10 That Member State shall provide for an appeal procedure in respect of such refusal.
  • chapter-vi/article-74/14 After 27 May 2029, all Member States shall be required to apply that procedure.
  • chapter-vi/article-76/2 The period for reporting shall take account of the severity of the event.
  • chapter-vii/section-1/article-78/3 The technical documentation shall be updated accordingly.
  • chapter-vii/section-1/article-81/1 Manufacturers of class C and D devices shall update the PSUR at least annually.
  • chapter-vii/section-2/article-84/4 The competent authority shall monitor the manufacturer's investigation of a serious incident.
  • chapter-vii/section-2/article-87/1 That electronic system shall include relevant links to the UDI database.
  • chapter-vii/section-3/article-88/6 The report shall set out any corrective actions needed.
  • chapter-vii/section-3/article-88/8 The Member States shall review and assess the functioning of their market surveillance activities.
  • chapter-vii/section-3/article-89 The relevant economic operators shall cooperate with the competent authorities.
  • chapter-vii/section-3/article-94/1 Where the measure is of general applicability, it shall be appropriately published.
  • chapter-viii/article-100/6 The EU reference laboratories may be granted a Union financial contribution.
  • chapter-ix/article-104/2 The structure and level of fees shall be made publicly available on request.
  • chapter-ix/article-106 The penalties provided for shall be effective, proportionate, and dissuasive.
  • chapter-x/article-107/1 That committee shall be a committee within the meaning of Regulation (EU) No 182/2011
  • chapter-x/article-108/3 It shall not affect the validity of any delegated acts already in force.
  • chapter-x/article-111 The evaluation shall also include a review on the functioning of Article 4.
  • chapter-x/article-113/2 It shall apply from 26 May 2022.
  • 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 Devices shall be sufficiently stable under the foreseen operating conditions.
  • annex-i/chapter-iii Any symbol or identification colour used shall conform to the harmonised standards or CS.
  • annex-ii/6.1.2.2 Analytical sensitivity This Section shall include information about the study design and results.
  • annex-ii/6.3.2 This may include open vial stability and/or, for automated instruments, on board stability.
  • 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 customised 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/3.7 Kits shall be assigned and bear their own UDI.
  • 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 minimised in order to reduce translations.
  • annex-vi/part-c/6.2.3 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 tits 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 EU reference laboratory shall provide a scientific opinion within 60 days.
  • annex-ix/chapter-ii The EU reference laboratory shall provide a scientific opinion within 60 days.
  • annex-ix/chapter-ii The EU reference laboratory shall inform the notified body about its findings.
  • annex-ix/chapter-ii The notified body shall convey its final decision to the medicinal products authority consulted.
  • annex-x/2 Application The manufacturer shall lodge an application for assessment with a notified body.
  • annex-x/3 The EU reference laboratory shall provide a scientific opinion within 60 days.
  • annex-x/4 The certificate shall be drawn up in accordance with Annex XII.
  • annex-x/5.4 The EU reference laboratory shall provide a scientific opinion within 60 days.
  • annex-x/6 Section 7 of Annex IX shall apply.
  • annex-xi/3.3 The first and second paragraphs of Section 2.3 of Annex IX shall apply.
  • annex-xi/3.3 The notified body shall notify the manufacturer of its decision to issue the certificate.
  • annex-xi/3.4 Section 2.4 of Annex IX shall apply.
  • annex-xi/5.1 The EU reference laboratory shall inform the notified body about its findings.
  • annex-xi/6 Section 7 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/part-a/1 The performance evaluation shall be thorough and objective, considering both favourable and unfavourable data.
  • annex-xiii/part-a/1.2.2 Analytical performance shall be demonstrated and documented in the analytical performance report.
  • annex-xiii/part-a/1.2.3 Clinical performance shall be demonstrated and documented in the clinical performance report.
  • annex-xiii/part-a/1.3.2 Performance evaluation report The clinical evidence shall be documented in a performance evaluation report.
  • annex-xiii/part-a/1.3.3 The performance evaluation report shall be part of the technical documentation.
  • annex-xiii/part-a/2.3.2 For studies using left-over samples, points (u), (x), (y) and (z) shall not apply.
  • annex-xiii/part-a/2.3.3 The results and conclusions shall be transparent, free of bias and clinically relevant.
  • annex-xiv/chapter-i/2 The IB shall be clearly identified and contain in particular the following information:
  • annex-xiv/chapter-ii/5 The sponsor shall complete the follow-up of investigation subjects.
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  • annex-xiii/part-a/1.2.1 2 withheld: over the quote cap
  • annex-xiii/part-a/1.2.2 4 withheld: over the quote cap
  • annex-xiii/part-a/1.2.3 3 withheld: over the quote cap
  • annex-xiii/part-a/1.3.1 4 withheld: over the quote cap
  • annex-xiii/part-a/1.3.2 2 withheld: over the quote cap
  • annex-xiii/part-a/1.3.3 2 withheld: over the quote cap
  • annex-xiii/part-a/2.1 1 withheld: over the quote cap
  • annex-xiii/part-a/2.2 1 withheld: over the quote cap
  • annex-xiii/part-a/2.3.1 1 withheld: over the quote cap
  • annex-xiii/part-a/2.3.2 5 withheld: over the quote cap
  • annex-xiii/part-a/2.3.3 3 withheld: over the quote cap
  • annex-xiii/part-a/3 1 withheld: over the quote cap
  • annex-xiii/part-b 9 withheld: over the quote cap
  • annex-xiv/chapter-i 1 withheld: over the quote cap
  • annex-xiv/chapter-i/1 2 withheld: over the quote cap
  • annex-xiv/chapter-i/2 2 withheld: over the quote cap
  • annex-xiv/chapter-i/4.2 1 withheld: over the quote cap
  • annex-xiv/chapter-i/4.6 1 withheld: over the quote cap
  • annex-xiv/chapter-ii/1 2 withheld: over the quote cap
  • annex-xiv/chapter-ii/2 1 withheld: over the quote cap
  • annex-xiv/chapter-ii/3 2 withheld: over the quote cap
  • annex-xiv/chapter-ii/4 1 withheld: over the quote cap

Source health#

Counts 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.

Fetch outcomes how the requests in the window answered
137 of 140 fetch records in the 90 calendar days ending carry no error. The 3 that carry one are recorded under blocked ×3. Of those, 47 produced a digest: a page that answers and is assembled in the browser answers without one.
Last fetched the most recent record in the whole series
— the latest day this record holds (). The method recorded is browser. What that record returned is in Observation history above.
Address stability where the requests actually landed
137 record(s) in the window recorded the address that answered, across 1 distinct address(es). 3 further record(s) carry no answered address and say nothing either way. The most recent answered address is the one this entry declares.
Access posture what the publisher declares, and what the requests met
Declared: no robots.txt published · crawlable partial · renders client-side. Met: 3 of 140 record(s) in the window were recorded as refused. A refusal is what one request of this record met on one day; it is not a policy the publisher stated.
Expected and observed cadence the declared term, the days held, and the days holding none
The term this record declares for this entry is quarterly. Over its own window, to , 98 of 98 calendar days hold at least one observation. None holds none. Every interval between consecutive days holding one is 1, counted in days. Both figures are stated and the difference between them is not adjudicated here.
Days by outcome each day of the document's window, by what the store holds for it
98 calendar days expected, 2026-07-28 to 2026-11-02 · 98 observed (31 digest-bearing, 67 retrieval failed) · 0 withheld · 0 no request recorded.
  • calendar days expected — one for each calendar day from the first observation classed as the document to the last day the store holds, because the collection is scheduled once a night; not the entry’s declared watch cadence
  • observed — a request for the document is recorded that day, and its record does not state that it was withheld or never left this machine
  • digest-bearing — a digest of the document is recorded that day
  • checked, unchanged (publisher-validator) — observed, and no digest of the document is recorded that day: the request carried an earlier reading’s validator and the server answered 304 “not modified”, which the record keeps as its outcome and basis; stated on a row only where the row has such a day
  • retrieval failed — observed, and no digest of the document is recorded that day
  • withheld — the day’s requests for the document are recorded as withheld, because the host’s filed terms withhold collection; none was sent
  • not sent, name unresolved here — the day’s requests for the document are recorded as never leaving this machine, because the host’s name did not resolve on it; attributable to this record, not to the host; stated on a row only where the row has such a day
  • no request recorded — no request for the document is recorded that day. This states what the store holds, not that no request was sent: the corrections page names the cause of each run of such days, including runs on which requests were sent and their records were not written
Retrieval limit
Digest-bearing on 31 of 98 calendar days expected; the publisher serves an automated-reader challenge (read 2026-09-28 at another document’s address on this host: HTTP 202, 2,035 bytes, a response header whose value is “challenge”), which this record does not run.

API and citation#

Cite this legal act

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.

Plain text

GxPlex. Regulation (EU) 2017/746 on in vitro diagnostic medical devices [legal act record]. Observed 2 November 2026. https://gxplex.com/r/eu-ivdr Primary source: https://eur-lex.europa.eu/eli/reg/2017/746/oj

BibTeX

@misc{gxplexreuivdr,
  author       = {{GxPlex}},
  title        = {{Regulation (EU) 2017/746 on in vitro diagnostic medical devices}},
  year         = {2026},
  note         = {legal act record, observed 2 November 2026},
  howpublished = {\url{https://gxplex.com/r/eu-ivdr}},
  urldate      = {2026-11-02},
  url          = {https://eur-lex.europa.eu/eli/reg/2017/746/oj}
}

APA

GxPlex. (2026). Regulation (EU) 2017/746 on in vitro diagnostic medical devices [legal act record]. Retrieved 2 November 2026, from https://gxplex.com/r/eu-ivdr

JSON

{
  "@context": "https://schema.org",
  "@type": "Dataset",
  "name": "Regulation (EU) 2017/746 on in vitro diagnostic medical devices",
  "publisher": "GxPlex",
  "url": "https://gxplex.com/r/eu-ivdr",
  "temporalCoverage": "2026-11-02",
  "observation": {
    "url": "https://gxplex.com/observations/eu-ivdr#obs-2026-11-02-1",
    "observedDate": "2026-11-02"
  },
  "isBasedOn": "https://eur-lex.europa.eu/eli/reg/2017/746/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.

Rights envelope — how this record handles the text of each entry listed
Entrytext_retainedlicence_classquote_allowedsnapshot_available
EU IVDRtrueopentruetrue
EU AI Acttrueopentruetrue
EU Cyber Resilience Acttrueopentruetrue
Regulation (EU) 2026/1744trueopentruetrue
EU MDRtrueopentruetrue
EU NIS2 Directivetrueopentruetrue

One row for the entry this page records, and one for each citing document whose words are quoted under “Cited by”.

Each value is read by the same function the API reads, and each field is defined in the published schema. None of the four is a grant.

Sources#

Listed primary first, then the further addresses this record holds for this entry, then the route it was found by, then dated third-party copies. Repeated URLs appear once, at their first position.

Last updated: