investigator
shared term, no equivalence asserted
The rows below print this term in 2 jurisdictions, set side by side by each row’s own jurisdiction field, in code-unit order of that field. Each definition is kept apart under its own text, and quoted where the term and its text together sit under the quote cap: 0 of 2 definitions in this view are quoted and 2 are withheld with the reason. No reading here says that two of them agree or differ.
EU
US
- Defined in
- no current text of a row of this jurisdiction defines it
- Rows printing it in a normative sentence
- 2
- Rows printing it in a title
- 0
- Rows printing it in body
- 1
This form is printed by the
tracked documents, each as a document defines it. The index’s key is
investigator (the definitions derivation’s fold:
case set aside, spaces collapsed; each form is matched exactly as printed).
3 observed texts define it.
Counts below are over each row’s current text, the
81 of 126 current
texts the derivation read; a title is read for every one of the 132 tracked rows.
Defined
2 definitions in 2 current texts, as the definitions derivation’s rules read them, quoted where the term and its text together sit under the quote cap.
- EU IVDR
EUtext first observedchapter-i/section-1/article-2(48)investigator: text withheld (over the cap: its term and text are 17 words)
- EU MDR
EUtext first observedchapter-i/article-2(54)investigator: text withheld (over the cap: its term and text are 17 words)
In normative sentences
91 sentences in 6 current texts
printing one of the forms in the heading and one of the sentence derivation’s listed verbs (shall, should, must, is expected, may). A sentence is a row of printed words; nothing here calls it a requirement. A defining occurrence that lies inside such a sentence is counted here and under Defined; only In body leaves out both.
Each sentence is given by the clause the sentence derivation places it under and the verbs it prints, grouped by clause, each clause followed by its count of sentences; its words are not quoted here, and are served by their offsets at /api/v1/modal-sentences.json.
- EMA CT computerised systems
EU55 sentences; text first observedid repeats in this text: 1 sentence (should) · follows a withheld heading: 23 sentences (may, should) · id repeats in this text: 31 sentences (should, is expected, may) - EU GMP Annex 13
EU1 sentence; text first observed6.4: 1 sentence (should) - EU IVDR
EU15 sentences; text first observedchapter-i/section-1/article-2: 1 sentence (shall, may) ·chapter-vi/article-58/7: 1 sentence (shall) ·chapter-vi/article-60/1: 1 sentence (may) ·chapter-vi/article-61/1: 1 sentence (may, shall) ·chapter-vi/article-64/1: 1 sentence (may) ·chapter-vi/article-64/2: 1 sentence (shall) ·chapter-vi/article-65/2: 1 sentence (shall) ·chapter-vi/article-67/4: 1 sentence (shall) ·chapter-vi/article-68/1: 1 sentence (shall) ·chapter-vi/article-68/3: 1 sentence (shall) ·chapter-vi/article-72/2: 1 sentence (shall) ·annex-xiii/part-a/2.3.2: 1 sentence (shall) ·annex-xiv/chapter-i/1: 1 sentence (shall, may) ·annex-xiv/chapter-i/2: 1 sentence (shall) ·annex-xiv/chapter-ii/2: 1 sentence (shall) - EU MDR
EU17 sentences; text first observedno clause anchor before this sentence: 1 sentence (should) ·chapter-i/article-2: 1 sentence (shall, may) ·chapter-ii/article-21/1: 1 sentence (shall) ·chapter-vi/article-62/6: 1 sentence (shall) ·chapter-vi/article-64/1: 1 sentence (may) ·chapter-vi/article-65: 1 sentence (may, shall) ·chapter-vi/article-68/1: 1 sentence (may) ·chapter-vi/article-68/2: 1 sentence (shall) ·chapter-vi/article-69/2: 1 sentence (shall) ·chapter-vi/article-71/4: 1 sentence (shall) ·chapter-vi/article-72/1: 1 sentence (shall) ·chapter-vi/article-72/3: 1 sentence (shall) ·chapter-vi/article-76/2: 1 sentence (shall) ·annex-xv/chapter-i/2.8: 1 sentence (shall) ·annex-xv/chapter-ii/1: 1 sentence (shall, may) ·annex-xv/chapter-ii/2: 1 sentence (shall) ·annex-xv/chapter-iii/2: 1 sentence (shall) - FDA electronic systems (clinical)
US2 sentences; text first observedno clause anchor before this sentence: 2 sentences (should) - FDA Part 11 scope
US1 sentence; text first observedno numbering read: 1 sentence (should)
In titles
0 tracked rows whose titles print one of the forms in the heading, read from the title this record holds, by the same exact rule.
No tracked row’s title prints it.
In body
22 occurrences in 4 current texts outside every sentence above and outside the term’s own definitions, each counted under the clause anchor the clause-anchor derivation placed last before it; each clause is followed by its count.
- EMA CT computerised systems
EU17 occurrences; text first observed17 where the heading before it is withheld - EU GMP Annex 13
EU1 occurrence; text first observed11.1: 1 - EU MDR
EU3 occurrences; text first observedannex-xv/chapter-ii/3.1.3: 3 - FDA electronic systems (clinical)
US1 occurrence; text first observed1 where no heading is read before it
Co-occurrence
103 other terms of the index share at least one clause of a current text with this one: a clause a definition sits in, the clause of a sentence above, or the clause a body occurrence is counted under. Terms in order of their key; each with the count of clauses shared and the clauses, by row. 77 positions of this term have no placed clause and share none (a defining occurrence inside a sentence above is counted once under each).
- accessory for a medical device 1 clause:
eu-mdrchapter-i/article-2 - accessory for an in vitro diagnostic medical device 1 clause:
eu-ivdrchapter-i/section-1/article-2 - active device 1 clause:
eu-mdrchapter-i/article-2 - adverse event 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - agglomerate 1 clause:
eu-mdrchapter-i/article-2 - aggregate 1 clause:
eu-mdrchapter-i/article-2 - analytical performance 2 clauses:
eu-ivdrannex-xiii/part-a/2.3.2·chapter-i/section-1/article-2 - Application 2 clauses:
eu-ivdrannex-xiv/chapter-i/1;eu-mdrannex-xv/chapter-ii/1 - authorised representative 4 clauses:
eu-ivdrannex-xiv/chapter-i/1·chapter-i/section-1/article-2;eu-mdrannex-xv/chapter-ii/1·chapter-i/article-2 - benefit-risk determination 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - calibrator 1 clause:
eu-ivdrchapter-i/section-1/article-2 - CE marking 3 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2·chapter-ii/article-21/1 - CE marking of conformity 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - clinical benefit 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - clinical data 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - clinical evaluation 2 clauses:
eu-mdrannex-xv/chapter-ii/1·chapter-i/article-2 - clinical evidence 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - clinical investigation 13 clauses:
eu-mdrannex-xv/chapter-i/2.8·annex-xv/chapter-ii/1·chapter-i/article-2·chapter-ii/article-21/1·chapter-vi/article-62/6·chapter-vi/article-64/1·chapter-vi/article-65·chapter-vi/article-68/1·chapter-vi/article-68/2·chapter-vi/article-69/2·chapter-vi/article-71/4·chapter-vi/article-72/1·chapter-vi/article-72/3 - clinical investigation plan 4 clauses:
eu-mdrannex-xv/chapter-ii/1·chapter-i/article-2·chapter-vi/article-68/1·chapter-vi/article-72/1 - clinical performance 5 clauses:
eu-ivdrannex-xiii/part-a/2.3.2·annex-xiv/chapter-i/1·chapter-i/section-1/article-2·chapter-vi/article-64/1;eu-mdrchapter-i/article-2 - companion diagnostic 1 clause:
eu-ivdrchapter-i/section-1/article-2 - conformity assessment 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - conformity assessment body 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - control material 1 clause:
eu-ivdrchapter-i/section-1/article-2 - corrective action 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - custom-made device 1 clause:
eu-mdrchapter-i/article-2 - derivative 2 clauses:
eu-mdrannex-xv/chapter-ii/1·chapter-i/article-2 - device deficiency 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - device for near-patient testing 1 clause:
eu-ivdrchapter-i/section-1/article-2 - device for performance study 3 clauses:
eu-ivdrannex-xiv/chapter-i/1·annex-xiv/chapter-i/2·chapter-i/section-1/article-2 - device for self-testing 1 clause:
eu-ivdrchapter-i/section-1/article-2 - diagnostic sensitivity 1 clause:
eu-ivdrchapter-i/section-1/article-2 - diagnostic specificity 1 clause:
eu-ivdrchapter-i/section-1/article-2 - distributor 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - economic operator 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - ethics committee 4 clauses:
eu-ivdrannex-xiv/chapter-i/1·chapter-i/section-1/article-2;eu-mdrannex-xv/chapter-ii/1·chapter-i/article-2 - European standard 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - falsified device 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - field safety corrective action 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - field safety notice 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - fully refurbishing 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - generic device group 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - harmonised standard 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - health institution 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - implantable device 1 clause:
eu-mdrchapter-i/article-2 - importer 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - in vitro diagnostic medical device 1 clause:
eu-ivdrchapter-i/section-1/article-2 - incident 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - informed consent 11 clauses:
eu-ivdrannex-xiii/part-a/2.3.2·chapter-i/section-1/article-2·chapter-vi/article-60/1·chapter-vi/article-61/1·chapter-vi/article-64/1·chapter-vi/article-64/2;eu-mdrchapter-i/article-2·chapter-vi/article-64/1·chapter-vi/article-65·chapter-vi/article-68/1·chapter-vi/article-68/2 - instructions for use 3 clauses:
eu-ivdrannex-xiii/part-a/2.3.2·chapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - intended purpose 3 clauses:
eu-ivdrannex-xiii/part-a/2.3.2·chapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - interventional clinical performance study 1 clause:
eu-ivdrchapter-i/section-1/article-2 - invasive device 1 clause:
eu-mdrchapter-i/article-2 - investigational device 3 clauses:
eu-mdrannex-xv/chapter-ii/1·annex-xv/chapter-ii/2·chapter-i/article-2 - kit 1 clause:
eu-ivdrchapter-i/section-1/article-2 - label 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - lay person 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - lifetime 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - likelihood ratio 1 clause:
eu-ivdrchapter-i/section-1/article-2 - making available on the market 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - manufacturer 7 clauses:
eu-gmp-annex-1311.1·6.4;eu-ivdrannex-xiii/part-a/2.3.2·annex-xiv/chapter-i/1·chapter-i/section-1/article-2;eu-mdrannex-xv/chapter-ii/1·chapter-i/article-2 - market surveillance 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - medical device 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - nanomaterial 1 clause:
eu-mdrchapter-i/article-2 - negative predictive value 1 clause:
eu-ivdrchapter-i/section-1/article-2 - non-viable 2 clauses:
eu-mdrannex-xv/chapter-ii/1·chapter-i/article-2 - notified body 4 clauses:
eu-ivdrannex-xiv/chapter-i/1·chapter-i/section-1/article-2;eu-mdrannex-xv/chapter-ii/1·chapter-i/article-2 - operator 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - particle 1 clause:
eu-mdrchapter-i/article-2 - performance 15 clauses:
eu-ivdrannex-xiii/part-a/2.3.2·annex-xiv/chapter-i/1·annex-xiv/chapter-i/2·chapter-i/section-1/article-2·chapter-vi/article-58/7·chapter-vi/article-60/1·chapter-vi/article-61/1·chapter-vi/article-64/1·chapter-vi/article-64/2·chapter-vi/article-65/2·chapter-vi/article-67/4·chapter-vi/article-68/1·chapter-vi/article-68/3;eu-mdrchapter-i/article-2·chapter-vi/article-71/4 - performance evaluation 2 clauses:
eu-ivdrannex-xiv/chapter-i/1·chapter-i/section-1/article-2 - performance of a device 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - performance study 13 clauses:
eu-ivdrannex-xiii/part-a/2.3.2·annex-xiv/chapter-i/1·annex-xiv/chapter-i/2·chapter-i/section-1/article-2·chapter-vi/article-58/7·chapter-vi/article-60/1·chapter-vi/article-61/1·chapter-vi/article-64/1·chapter-vi/article-64/2·chapter-vi/article-65/2·chapter-vi/article-67/4·chapter-vi/article-68/1·chapter-vi/article-68/3 - performance study plan 6 clauses:
eu-ivdrannex-xiii/part-a/2.3.2·annex-xiv/chapter-i/1·chapter-i/section-1/article-2·chapter-vi/article-64/1·chapter-vi/article-67/4·chapter-vi/article-68/1 - personal data 2 clauses:
eu-ivdrchapter-vi/article-68/3;eu-mdrchapter-vi/article-72/3 - placing on the market 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - positive predictive value 1 clause:
eu-ivdrchapter-i/section-1/article-2 - post-market surveillance 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - predictive value 1 clause:
eu-ivdrchapter-i/section-1/article-2 - procedure pack 1 clause:
eu-mdrchapter-i/article-2 - professional user 1 clause:
eu-mdrchapter-i/article-2 - putting into service 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - recall 3 clauses:
eu-gmp-annex-1311.1;eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - representative 14 clauses:
eu-gmp-annex-1311.1;eu-ivdrannex-xiii/part-a/2.3.2·annex-xiv/chapter-i/1·chapter-i/section-1/article-2·chapter-vi/article-60/1·chapter-vi/article-61/1·chapter-vi/article-64/1·chapter-vi/article-64/2;eu-mdrannex-xv/chapter-ii/1·chapter-i/article-2·chapter-vi/article-64/1·chapter-vi/article-65·chapter-vi/article-68/1·chapter-vi/article-68/2 - reprocessing 1 clause:
eu-mdrchapter-i/article-2 - Risk / risk 6 clauses:
eu-ivdrchapter-i/section-1/article-2·chapter-vi/article-60/1·chapter-vi/article-61/1·chapter-vi/article-64/1;eu-mdrchapter-i/article-2·chapter-vi/article-68/1 - scientific validity of an analyte 1 clause:
eu-ivdrchapter-i/section-1/article-2 - serious adverse event 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - serious incident 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - serious public health threat 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - single-use device 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - software 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - specimen receptacle 1 clause:
eu-ivdrchapter-i/section-1/article-2 - sponsor 16 clauses:
eu-gmp-annex-1311.1;eu-ivdrannex-xiii/part-a/2.3.2·annex-xiv/chapter-i/1·annex-xiv/chapter-ii/2·chapter-i/section-1/article-2·chapter-vi/article-65/2·chapter-vi/article-68/1·chapter-vi/article-68/3·chapter-vi/article-72/2;eu-mdrannex-xv/chapter-ii/1·annex-xv/chapter-iii/2·chapter-i/article-2·chapter-vi/article-69/2·chapter-vi/article-72/1·chapter-vi/article-72/3·chapter-vi/article-76/2 - standard 6 clauses:
eu-ivdrchapter-i/section-1/article-2·chapter-vi/article-60/1·chapter-vi/article-61/1·chapter-vi/article-64/1;eu-mdrchapter-i/article-2·chapter-vi/article-68/1 - subject 11 clauses:
eu-ivdrchapter-i/section-1/article-2·chapter-vi/article-60/1·chapter-vi/article-61/1·chapter-vi/article-64/1·chapter-vi/article-64/2;eu-mdrannex-xv/chapter-ii/1·chapter-i/article-2·chapter-vi/article-64/1·chapter-vi/article-65·chapter-vi/article-68/1·chapter-vi/article-68/2 - System / system 4 clauses:
eu-ivdrchapter-i/section-1/article-2·chapter-vi/article-65/2;eu-mdrchapter-i/article-2·chapter-vi/article-69/2 - UDI 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - Union harmonisation legislation 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - Unique Device Identifier 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - user 3 clauses:
eu-ivdrannex-xiii/part-a/2.3.2·chapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - withdrawal 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - written 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2
History
Every text of each row holding the term in any text the store holds under the current version, in the order the texts were first observed. A row’s current text is marked.
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
90f72782b398 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
ebaf707c409d (current) | 0 | 55 | 17 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
48f21f2e4f1b unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
c4635c9c95ba (current) | 0 | 1 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
903e40aaebe6 (current) | 1 | 15 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
14d00b77d5c8 | 1 | 17 | 3 | |
fab624c8e1dc (current) | 1 | 17 | 3 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
06b24bf9ebcb unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
74c586849092 (current) | 0 | 2 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
a5590943862c (current) | 0 | 1 | 0 |
Feed
/atom/term/investigator.atom carries one entry for each text of a row whose counts above differ from the row’s previous text, and one for the first text of a row holding the term, dated by the text’s first observation. A new version of the derivation is a change of method and is never an entry.
How this page is derived
From the terms-index derivation’s current version, first derived on
, read from
state/terms-index.jsonl. Threshold: a key enters the index when at least 1 observed text of a tracked row defines it, under the definitions derivation's current version. Its version, its rules and
term set, and the versions of the clause-anchor, definitions and sentence derivations it joins, are on
the derivation methods page, which lists every version of each with
the day it was first derived: a change there is a change of method, never a change in a text.
Not read: a term printed in a form no definition under its key carries: a plural or other ending, another letter case, another spacing or a line break between its words, a hyphenated or abbreviated form, a translation; a term a document defines in a form head 3's rules do not read (its own not_reached names them), which enters no key; an occurrence in a text head 1 refused, which is not read; a title is read for its row and is not dated by a text. A position states where an occurrence lies in a text and nothing about what the text says of the term.
| Entry | text_retained | licence_class | quote_allowed | snapshot_available |
|---|---|---|---|---|
| EU IVDR | true | open | true | true |
| EU MDR | true | open | true | true |
| EU GMP Annex 11 | true | open | true | true |
| EU AI Act | true | open | true | true |
| EU Cyber Resilience Act | true | open | true | true |
| EU Machinery Regulation | true | open | true | true |
| EU Cybersecurity Act | true | open | true | true |
| EU NIS2 Directive | true | open | true | true |
| ICH Q9(R1) | true | open | true | true |
| ICH Q13 | true | open | true | true |
| EU GMP Chapter 4 | true | open | true | true |
One row for each entry whose own characters this page prints: a text defining a form printed here, or a definition quoted. A row named or linked without its characters printed, or whose title only or sentence clauses only are given, has no row.
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.
Last updated: