market surveillance
shared term, no equivalence asserted
The rows below print this term in 4 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.
Canada
- Defined in
- no current text of a row of this jurisdiction defines it
- Rows printing it in a normative sentence
- 0
- Rows printing it in a title
- 0
- Rows printing it in body
- 1
EU
International
- Defined in
- no current text of a row of this jurisdiction defines it
- Rows printing it in a normative sentence
- 0
- Rows printing it in a title
- 0
- Rows printing it in body
- 1
UK
- Defined in
- no current text of a row of this jurisdiction defines it
- Rows printing it in a normative sentence
- 0
- 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
market surveillance (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(64)market surveillance: text withheld (over the cap: its term and text are 45 words)
- EU MDR
EUtext first observedchapter-i/article-2(61)market surveillance: text withheld (over the cap: its term and text are 45 words)
In normative sentences
426 sentences in 7 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.
- EU AI Act
EU115 sentences; text first observedno clause anchor before this sentence: 22 sentences (should, may) ·chapter-i/article-3: 1 sentence (may, shall) ·chapter-ii/article-5/4: 1 sentence (shall) ·chapter-ii/article-5/6: 2 sentences (shall) ·chapter-iii/section-3/article-20/2: 1 sentence (shall) ·chapter-iii/section-3/article-22/3: 1 sentence (shall) ·chapter-iii/section-3/article-22/4: 1 sentence (shall) ·chapter-iii/section-3/article-23/2: 1 sentence (shall) ·chapter-iii/section-3/article-26/5: 2 sentences (may, shall) ·chapter-iii/section-3/article-26/10: 2 sentences (shall) ·chapter-iii/section-3/article-27/3: 1 sentence (shall) ·chapter-iii/section-4/article-36/6: 1 sentence (shall) ·chapter-iii/section-5/article-43/1: 1 sentence (shall) ·chapter-iii/section-5/article-45/1: 1 sentence (shall) ·chapter-iii/section-5/article-46/1: 1 sentence (may) ·chapter-iii/section-5/article-46/3: 2 sentences (shall) ·chapter-iii/section-5/article-46/4: 1 sentence (shall) ·chapter-iii/section-5/article-46/5: 1 sentence (shall) ·chapter-iii/section-5/article-46/6: 1 sentence (shall) ·chapter-vi/article-57/7: 2 sentences (may, shall) ·chapter-vi/article-60/4: 1 sentence (may, shall) ·chapter-vi/article-60/6: 1 sentence (shall) ·chapter-vi/article-60/7: 1 sentence (shall) ·chapter-vi/article-60/8: 1 sentence (shall) ·chapter-vii/section-1/article-65/6: 2 sentences (shall, should) ·chapter-vii/section-1/article-66: 1 sentence (may) ·chapter-vii/section-1/article-68/3: 1 sentence (shall) ·chapter-vii/section-2/article-70/1: 1 sentence (shall) ·chapter-vii/section-2/article-70/2: 2 sentences (shall) ·chapter-viii/article-71/4: 1 sentence (shall) ·chapter-ix/section-2/article-73/1: 1 sentence (shall) ·chapter-ix/section-2/article-73/7: 1 sentence (shall) ·chapter-ix/section-2/article-73/8: 1 sentence (shall) ·chapter-ix/section-3/article-74/2: 1 sentence (shall, may) ·chapter-ix/section-3/article-74/3: 2 sentences (shall, may) ·chapter-ix/section-3/article-74/5: 1 sentence (may) ·chapter-ix/section-3/article-74/6: 1 sentence (shall) ·chapter-ix/section-3/article-74/7: 2 sentences (may, should) ·chapter-ix/section-3/article-74/8: 1 sentence (shall) ·chapter-ix/section-3/article-74/9: 1 sentence (shall) ·chapter-ix/section-3/article-74/10: 1 sentence (shall) ·chapter-ix/section-3/article-74/11: 1 sentence (shall) ·chapter-ix/section-3/article-74/12: 1 sentence (shall) ·chapter-ix/section-3/article-74/14: 1 sentence (shall) ·chapter-ix/section-3/article-75/1: 1 sentence (shall) ·chapter-ix/section-3/article-75/2: 1 sentence (shall) ·chapter-ix/section-3/article-75/3: 1 sentence (may, shall) ·chapter-ix/section-3/article-76/2: 1 sentence (shall) ·chapter-ix/section-3/article-76/3: 1 sentence (may) ·chapter-ix/section-3/article-76/4: 1 sentence (shall) ·chapter-ix/section-3/article-76/5: 1 sentence (shall) ·chapter-ix/section-3/article-77/1: 1 sentence (shall) ·chapter-ix/section-3/article-77/3: 2 sentences (may, shall) ·chapter-ix/section-3/article-78/1: 1 sentence (shall) ·chapter-ix/section-3/article-78/3: 2 sentences (shall) ·chapter-ix/section-3/article-79/2: 5 sentences (shall, may) ·chapter-ix/section-3/article-79/3: 1 sentence (shall) ·chapter-ix/section-3/article-79/5: 1 sentence (shall) ·chapter-ix/section-3/article-79/6: 1 sentence (shall) ·chapter-ix/section-3/article-79/7: 1 sentence (shall) ·chapter-ix/section-3/article-79/8: 1 sentence (shall) ·chapter-ix/section-3/article-79/9: 1 sentence (shall) ·chapter-ix/section-3/article-80/1: 1 sentence (shall) ·chapter-ix/section-3/article-80/2: 1 sentence (shall, may) ·chapter-ix/section-3/article-80/3: 1 sentence (shall) ·chapter-ix/section-3/article-80/7: 1 sentence (shall) ·chapter-ix/section-3/article-80/8: 1 sentence (may) ·chapter-ix/section-3/article-81/1: 3 sentences (shall) ·chapter-ix/section-3/article-82/1: 1 sentence (shall, may) ·chapter-ix/section-3/article-82/2: 1 sentence (shall) ·chapter-ix/section-3/article-83/1: 1 sentence (shall, may) ·chapter-ix/section-3/article-83/2: 1 sentence (shall) ·chapter-ix/section-3/article-84/2: 1 sentence (shall) ·chapter-ix/section-4/article-85: 2 sentences (may, shall) ·chapter-ix/section-5/article-88/2: 1 sentence (may) ·chapter-xii/article-99/7: 1 sentence (shall) - EU Cyber Resilience Act
EU126 sentences; text first observedno clause anchor before this sentence: 36 sentences (should, is expected, may) ·chapter-i/article-3: 1 sentence (may) ·chapter-i/article-10: 1 sentence (shall) ·chapter-ii/article-13/8: 1 sentence (may) ·chapter-ii/article-13/13: 1 sentence (shall) ·chapter-ii/article-13/16: 1 sentence (shall) ·chapter-ii/article-13/18: 2 sentences (shall) ·chapter-ii/article-13/22: 1 sentence (shall) ·chapter-ii/article-13/23: 1 sentence (shall) ·chapter-ii/article-13/25: 2 sentences (may) ·chapter-ii/article-16/3: 1 sentence (shall) ·chapter-ii/article-18/3: 2 sentences (shall) ·chapter-ii/article-19/2: 1 sentence (shall) ·chapter-ii/article-19/3: 3 sentences (shall, may) ·chapter-ii/article-19/4: 1 sentence (shall) ·chapter-ii/article-19/5: 1 sentence (shall) ·chapter-ii/article-19/6: 1 sentence (shall) ·chapter-ii/article-19/7: 1 sentence (shall) ·chapter-ii/article-19/8: 1 sentence (shall) ·chapter-ii/article-20/3: 1 sentence (shall) ·chapter-ii/article-20/4: 1 sentence (shall) ·chapter-ii/article-20/5: 1 sentence (shall) ·chapter-ii/article-20/6: 1 sentence (shall) ·chapter-ii/article-23/1: 1 sentence (shall) ·chapter-ii/article-24/2: 2 sentences (shall) ·chapter-iii/article-33/2: 2 sentences (shall) ·chapter-iv/article-39/10: 1 sentence (shall) ·chapter-iv/article-45/2: 1 sentence (shall) ·chapter-iv/article-49/1: 1 sentence (shall) ·chapter-v/article-52/2: 2 sentences (shall, may) ·chapter-v/article-52/3: 2 sentences (shall) ·chapter-v/article-52/4: 2 sentences (shall) ·chapter-v/article-52/5: 2 sentences (may) ·chapter-v/article-52/6: 1 sentence (shall) ·chapter-v/article-52/7: 1 sentence (shall) ·chapter-v/article-52/8: 1 sentence (shall) ·chapter-v/article-52/9: 1 sentence (shall) ·chapter-v/article-52/13: 2 sentences (shall, may) ·chapter-v/article-52/14: 3 sentences (shall) ·chapter-v/article-52/15: 2 sentences (shall) ·chapter-v/article-52/16: 1 sentence (may) ·chapter-v/article-53: 1 sentence (shall) ·chapter-v/article-54/1: 4 sentences (shall, may) ·chapter-v/article-54/2: 2 sentences (shall) ·chapter-v/article-54/3: 1 sentence (shall) ·chapter-v/article-54/5: 1 sentence (shall) ·chapter-v/article-54/6: 1 sentence (shall) ·chapter-v/article-54/7: 1 sentence (shall) ·chapter-v/article-54/9: 1 sentence (shall) ·chapter-v/article-56/1: 2 sentences (shall, may) ·chapter-v/article-56/2: 1 sentence (shall) ·chapter-v/article-56/3: 2 sentences (shall, may) ·chapter-v/article-57/1: 1 sentence (shall) ·chapter-v/article-57/2: 1 sentence (shall) ·chapter-v/article-57/6: 1 sentence (shall, may) ·chapter-v/article-57/7: 1 sentence (shall, may) ·chapter-v/article-58/1: 1 sentence (shall) ·chapter-v/article-59/2: 1 sentence (shall) ·chapter-v/article-59/3: 1 sentence (shall) ·chapter-v/article-59/4: 1 sentence (may) ·chapter-v/article-59/5: 1 sentence (shall) ·chapter-v/article-60/2: 1 sentence (shall) ·chapter-v/article-60/3: 1 sentence (may, shall) ·chapter-v/article-60/4: 1 sentence (may) ·chapter-vii/article-63/2: 1 sentence (shall) ·chapter-vii/article-64/4: 1 sentence (shall) ·chapter-vii/article-64/5: 1 sentence (shall) ·chapter-vii/article-64/6: 1 sentence (shall) ·chapter-vii/article-64/9: 1 sentence (may) ·annex-vii: 1 sentence (shall) - EU Cybersecurity Act
EU2 sentences; text first observedno clause anchor before this sentence: 1 sentence (should) ·title-iii/article-58/7: 1 sentence (shall) - Regulation (EU) 2026/1744
EU21 sentences; text first observedno clause anchor before this sentence: 5 sentences (should) ·article-1/6: 12 sentences (shall, may) ·article-1/9: 4 sentences (shall) - EU IVDR
EU63 sentences; text first observedno clause anchor before this sentence: 12 sentences (should, may) ·chapter-i/section-1/article-2: 1 sentence (shall, may) ·chapter-ii/article-8/1: 1 sentence (shall) ·chapter-ii/article-10/8: 1 sentence (shall) ·chapter-ii/article-10/9: 1 sentence (shall) ·chapter-ii/article-15/3: 1 sentence (shall) ·chapter-iii/article-30/2: 1 sentence (shall) ·chapter-iv/article-40/6: 1 sentence (shall) ·chapter-iv/article-41/5: 1 sentence (may) ·chapter-iv/article-42/6: 1 sentence (shall) ·chapter-v/section-1/article-47/3: 1 sentence (shall) ·chapter-vi/article-56/6: 1 sentence (shall) ·chapter-vii/section-1/article-78/1: 1 sentence (shall) ·chapter-vii/section-1/article-78/2: 1 sentence (shall) ·chapter-vii/section-1/article-78/3: 1 sentence (shall) ·chapter-vii/section-1/article-78/4: 1 sentence (shall) ·chapter-vii/section-1/article-79: 2 sentences (shall) ·chapter-vii/section-1/article-80: 1 sentence (shall) ·chapter-vii/section-1/article-81/1: 1 sentence (shall) ·chapter-vii/section-2/article-83/1: 1 sentence (shall) ·chapter-vii/section-2/article-86: 1 sentence (may) ·chapter-vii/section-3/article-88/2: 1 sentence (shall) ·chapter-vii/section-3/article-88/8: 1 sentence (shall) ·chapter-vii/section-3/article-88/9: 2 sentences (shall) ·chapter-vii/section-3/article-88/10: 1 sentence (shall) ·chapter-vii/section-3/article-88/11: 1 sentence (shall) ·chapter-vii/section-3/article-89: 1 sentence (may, shall) ·chapter-vii/section-3/article-95/1: 1 sentence (shall) ·chapter-vii/section-3/article-95/3: 1 sentence (shall) ·chapter-viii/article-99: 1 sentence (shall) ·chapter-viii/article-100/2: 1 sentence (shall) ·chapter-x/article-110/3: 1 sentence (shall) ·annex-i/chapter-i/3: 1 sentence (shall) ·annex-iii: 1 sentence (shall) ·annex-iii/1: 1 sentence (shall) ·annex-vii/4.5.2: 1 sentence (shall) ·annex-vii/4.5.4: 2 sentences (shall) ·annex-vii/4.8: 1 sentence (shall) ·annex-vii/4.10: 2 sentences (shall) ·annex-vii/4.11: 2 sentences (shall) ·annex-ix/chapter-i/2.1: 1 sentence (shall) ·annex-ix/chapter-i/3.2: 1 sentence (shall) ·annex-ix/chapter-i/3.3: 1 sentence (shall) ·annex-ix/chapter-ii: 2 sentences (shall) ·annex-xiii/part-a/1.3.3: 1 sentence (shall) ·annex-xiii/part-b: 1 sentence (shall) - EU Machinery Regulation
EU35 sentences; text first observedno clause anchor before this sentence: 8 sentences (should, may) ·chapter-i/article-3: 1 sentence (may) ·chapter-i/article-6/5: 1 sentence (shall) ·chapter-i/article-6/7: 1 sentence (shall) ·chapter-ii/article-10/3: 1 sentence (shall) ·chapter-ii/article-10/6: 1 sentence (shall) ·chapter-ii/article-11/3: 1 sentence (shall) ·chapter-ii/article-11/6: 1 sentence (shall) ·chapter-ii/article-12/2: 1 sentence (shall) ·chapter-ii/article-13/2: 1 sentence (shall) ·chapter-ii/article-13/3: 1 sentence (shall) ·chapter-ii/article-13/8: 1 sentence (shall) ·chapter-ii/article-14/2: 1 sentence (shall) ·chapter-ii/article-14/3: 1 sentence (shall) ·chapter-ii/article-14/7: 1 sentence (shall) ·chapter-ii/article-15/3: 1 sentence (shall) ·chapter-ii/article-16/3: 1 sentence (shall) ·chapter-ii/article-19/1: 1 sentence (shall) ·chapter-v/article-36/2: 1 sentence (shall) ·chapter-v/article-40/1: 1 sentence (shall) ·chapter-vi/article-43/1: 4 sentences (shall) ·chapter-vi/article-43/2: 1 sentence (shall) ·chapter-vi/article-43/4: 2 sentences (shall) ·chapter-vi/article-43/5: 1 sentence (shall) - EU MDR
EU64 sentences; text first observedno clause anchor before this sentence: 12 sentences (should, may) ·chapter-i/article-2: 1 sentence (shall, may) ·chapter-ii/article-8/1: 1 sentence (shall) ·chapter-ii/article-10/9: 1 sentence (shall) ·chapter-ii/article-10/10: 1 sentence (shall) ·chapter-ii/article-15/3: 1 sentence (shall) ·chapter-iii/article-33/2: 1 sentence (shall) ·chapter-iv/article-44/6: 1 sentence (shall) ·chapter-iv/article-45/5: 1 sentence (may) ·chapter-iv/article-46/6: 1 sentence (shall) ·chapter-v/section-1/article-51/3: 1 sentence (shall) ·chapter-vi/article-61/9: 1 sentence (shall) ·chapter-vi/article-61/11: 1 sentence (shall) ·chapter-vii/section-1/article-83/1: 1 sentence (shall) ·chapter-vii/section-1/article-83/2: 1 sentence (shall) ·chapter-vii/section-1/article-83/3: 1 sentence (shall) ·chapter-vii/section-1/article-83/4: 1 sentence (shall) ·chapter-vii/section-1/article-84: 2 sentences (shall) ·chapter-vii/section-1/article-85: 1 sentence (shall) ·chapter-vii/section-1/article-86/1: 1 sentence (shall) ·chapter-vii/section-2/article-88/1: 1 sentence (shall) ·chapter-vii/section-2/article-91: 1 sentence (may) ·chapter-vii/section-3/article-93/2: 1 sentence (shall) ·chapter-vii/section-3/article-93/8: 1 sentence (shall) ·chapter-vii/section-3/article-93/9: 2 sentences (shall) ·chapter-vii/section-3/article-93/10: 1 sentence (shall) ·chapter-vii/section-3/article-93/11: 1 sentence (shall) ·chapter-vii/section-3/article-94: 1 sentence (may, shall) ·chapter-vii/section-3/article-100/1: 1 sentence (shall) ·chapter-vii/section-3/article-100/3: 1 sentence (shall) ·chapter-viii/article-105: 1 sentence (shall) ·chapter-x/article-120/3: 1 sentence (shall) ·annex-i/chapter-i/3: 1 sentence (shall) ·annex-iii: 2 sentences (shall) ·annex-vii/4.5.2: 2 sentences (shall) ·annex-vii/4.5.5: 2 sentences (shall) ·annex-vii/4.8: 1 sentence (shall) ·annex-vii/4.10: 2 sentences (shall) ·annex-vii/4.11: 2 sentences (shall) ·annex-ix/chapter-i/2.1: 1 sentence (shall) ·annex-ix/chapter-i/3.2: 1 sentence (shall) ·annex-ix/chapter-i/3.3: 1 sentence (shall) ·annex-ix/chapter-ii: 2 sentences (shall) ·annex-xi/part-b: 1 sentence (shall) ·annex-xiv/part-b: 1 sentence (shall)
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
52 occurrences in 10 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.
- Annex 15 revision concept paper
International1 occurrence; text first observed1: 1 - EU AI Act
EU14 occurrences; text first observedannex-i/14: 1 ·annex-i/15: 1 ·annex-i/18: 1 ·chapter-i/article-1/2: 1 ·chapter-ix/section-3/article-75: 1 ·chapter-ix/section-3/article-76: 1 ·chapter-xiii/article-113: 4 · 4 where no heading is read before it - EU Cyber Resilience Act
EU9 occurrences; text first observedchapter-i/article-1: 1 ·chapter-v/article-59: 1 ·chapter-viii/article-71/2: 2 · 5 where no heading is read before it - EU Cybersecurity Act
EU1 occurrence; text first observedtitle-iv/article-69/2: 1 - Regulation (EU) 2026/1744
EU3 occurrences; text first observedarticle-4: 1 · 2 where no heading is read before it - EU IVDR
EU8 occurrences; text first observedannex-iii/1: 1 ·annex-iii/2: 1 ·chapter-vii/section-1: 1 ·chapter-vii/section-1/article-78: 1 ·chapter-vii/section-2/article-87: 1 ·chapter-vii/section-3/article-95: 1 ·chapter-x/article-113/3: 2 - EU Machinery Regulation
EU5 occurrences; text first observedchapter-ix/article-54: 4 · 1 where no heading is read before it - EU MDR
EU8 occurrences; text first observedannex-iii: 2 ·chapter-vii/section-1: 1 ·chapter-vii/section-1/article-83: 1 ·chapter-vii/section-2/article-92: 1 ·chapter-vii/section-3/article-100: 1 ·chapter-x/article-123/3: 2 - Health Canada ML
Canada1 occurrence; text first observed1 where no numbering read in this text - MHRA AI Airlock
UK2 occurrences; text first observed2 where no numbering read in this text
Co-occurrence
204 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. 111 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 - accreditation 8 clauses:
eu-ai-actchapter-xiii/article-113;eu-cyber-resilience-actchapter-viii/article-71/2;eu-cybersecurity-acttitle-iii/article-58/7·title-iv/article-69/2;eu-ivdrchapter-x/article-113/3;eu-machinery-regulationchapter-i/article-3·chapter-ix/article-54;eu-mdrchapter-x/article-123/3 - Act 4 clauses:
eu-ai-actchapter-xiii/article-113;eu-cyber-resilience-actchapter-viii/article-71/2;eu-digital-omnibus-aiarticle-4;eu-machinery-regulationchapter-ix/article-54 - active device 1 clause:
eu-mdrchapter-i/article-2 - actively exploited vulnerability 2 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-16/3 - adverse event 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - Agency 6 clauses:
eu-ai-actchapter-xiii/article-113;eu-cyber-resilience-actchapter-viii/article-71/2;eu-cybersecurity-acttitle-iv/article-69/2;eu-digital-omnibus-aiarticle-4;eu-machinery-regulationchapter-ix/article-54;eu-mdrchapter-x/article-123/3 - agglomerate 1 clause:
eu-mdrchapter-i/article-2 - aggregate 1 clause:
eu-mdrchapter-i/article-2 - AI literacy 2 clauses:
eu-ai-actchapter-i/article-3·chapter-vii/section-1/article-66 - AI Office 9 clauses:
eu-ai-actchapter-i/article-3·chapter-ix/section-3/article-74/11·chapter-ix/section-3/article-75/1·chapter-ix/section-3/article-75/2·chapter-ix/section-3/article-75/3·chapter-vii/section-1/article-66·chapter-vii/section-1/article-68/3;eu-digital-omnibus-aiarticle-1/6·article-1/9 - AI regulatory sandbox 4 clauses:
eu-ai-actchapter-i/article-3·chapter-ix/section-3/article-76/2·chapter-vi/article-57/7;eu-digital-omnibus-aiarticle-1/6 - AI system 29 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-20/2·chapter-iii/section-3/article-22/3·chapter-iii/section-3/article-23/2·chapter-iii/section-3/article-26/10·chapter-iii/section-3/article-26/5·chapter-iii/section-5/article-43/1·chapter-iii/section-5/article-46/3·chapter-ix/section-3/article-74/6·chapter-ix/section-3/article-75/1·chapter-ix/section-3/article-75/3·chapter-ix/section-3/article-76/5·chapter-ix/section-3/article-77/3·chapter-ix/section-3/article-79/2·chapter-ix/section-3/article-79/5·chapter-ix/section-3/article-79/6·chapter-ix/section-3/article-79/7·chapter-ix/section-3/article-79/9·chapter-ix/section-3/article-80/1·chapter-ix/section-3/article-80/2·chapter-ix/section-3/article-80/3·chapter-ix/section-3/article-80/7·chapter-ix/section-3/article-82/1·chapter-ix/section-3/article-83/2·chapter-vi/article-57/7·chapter-vi/article-60/4·chapter-vi/article-60/7·chapter-xii/article-99/7;eu-digital-omnibus-aiarticle-1/6 - analytical performance 1 clause:
eu-ivdrchapter-i/section-1/article-2 - Application 2 clauses:
eu-digital-omnibus-aiarticle-1/9;eu-mdrannex-xi/part-b - authorised representative 14 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-22/3·chapter-iii/section-3/article-22/4·chapter-iii/section-3/article-23/2·chapter-ix/section-3/article-83/1;eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-18/3;eu-ivdrannex-ix/chapter-i/2.1·chapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3·chapter-ii/article-12/2;eu-mdrannex-ix/chapter-i/2.1·annex-xi/part-b·chapter-i/article-2 - benefit-risk determination 8 clauses:
eu-ivdrannex-ix/chapter-ii·chapter-i/section-1/article-2·chapter-vii/section-1/article-78/3·chapter-vii/section-1/article-81/1;eu-mdrannex-ix/chapter-ii·chapter-i/article-2·chapter-vii/section-1/article-83/3·chapter-vii/section-1/article-86/1 - biometric categorisation system 1 clause:
eu-ai-actchapter-i/article-3 - biometric data 2 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-26/10 - biometric identification 5 clauses:
eu-ai-actchapter-i/article-3·chapter-ii/article-5/4·chapter-ii/article-5/6·chapter-iii/section-3/article-26/10;eu-digital-omnibus-aiarticle-1/9 - biometric verification 1 clause:
eu-ai-actchapter-i/article-3 - calibrator 1 clause:
eu-ivdrchapter-i/section-1/article-2 - CE marking 13 clauses:
eu-ai-actchapter-i/article-3·chapter-ix/section-3/article-83/1;eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-19/2·chapter-v/article-58/1;eu-ivdrannex-xiii/part-b·chapter-i/section-1/article-2·chapter-x/article-113/3;eu-machinery-regulationchapter-i/article-3·chapter-ii/article-13/2;eu-mdrannex-xiv/part-b·chapter-i/article-2·chapter-x/article-123/3 - CE marking of conformity 4 clauses:
eu-ivdrchapter-i/section-1/article-2·chapter-x/article-113/3;eu-mdrchapter-i/article-2·chapter-x/article-123/3 - chains 5 clauses:
eu-ai-actchapter-vii/section-1/article-66;eu-cyber-resilience-actchapter-v/article-54/2·chapter-v/article-56/2;eu-machinery-regulationchapter-i/article-3·chapter-ix/article-54 - clinical benefit 3 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2·chapter-vi/article-61/9 - clinical data 11 clauses:
eu-ivdrannex-vii/4.10·annex-vii/4.11·chapter-i/section-1/article-2;eu-mdrannex-ix/chapter-ii·annex-vii/4.10·annex-vii/4.11·annex-vii/4.5.5·annex-xiv/part-b·chapter-i/article-2·chapter-vi/article-61/11·chapter-vi/article-61/9 - clinical evaluation 13 clauses:
eu-mdrannex-ix/chapter-i/2.1·annex-ix/chapter-ii·annex-vii/4.10·annex-vii/4.11·annex-vii/4.5.5·annex-vii/4.8·annex-xiv/part-b·chapter-i/article-2·chapter-ii/article-10/9·chapter-ii/article-8/1·chapter-iv/article-45/5·chapter-vi/article-61/11·chapter-vii/section-1/article-83/3 - clinical evidence 9 clauses:
eu-ivdrannex-ix/chapter-ii·annex-vii/4.5.4·annex-xiii/part-a/1.3.3·annex-xiii/part-b·chapter-i/section-1/article-2·chapter-ii/article-8/1;eu-mdrannex-ix/chapter-ii·annex-vii/4.5.5·chapter-i/article-2 - clinical investigation 4 clauses:
eu-mdrannex-vii/4.5.5·chapter-i/article-2·chapter-vi/article-61/9·chapter-viii/article-105 - clinical investigation plan 2 clauses:
eu-mdrannex-vii/4.5.5·chapter-i/article-2 - clinical performance 7 clauses:
eu-ivdrannex-xiii/part-b·chapter-i/section-1/article-2·chapter-ii/article-15/3·chapter-x/article-113/3;eu-mdrchapter-i/article-2·chapter-vi/article-61/11·chapter-vii/section-1/article-83/3 - common specification 1 clause:
eu-ai-actchapter-i/article-3 - companion diagnostic 2 clauses:
eu-ivdrannex-ix/chapter-ii·chapter-i/section-1/article-2 - Component / component 3 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-machinery-regulationchapter-i/article-3 - conformity assessment 37 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-22/3·chapter-iii/section-5/article-43/1·chapter-iii/section-5/article-45/1·chapter-iii/section-5/article-46/1·chapter-vi/article-57/7·chapter-vii/section-1/article-66;eu-cyber-resilience-actchapter-i/article-10·chapter-i/article-3·chapter-ii/article-19/2·chapter-iv/article-39/10·chapter-iv/article-49/1·chapter-v/article-58/1;eu-cybersecurity-acttitle-iii/article-58/7·title-iv/article-69/2;eu-digital-omnibus-aiarticle-1/6·article-1/9;eu-ivdrannex-ix/chapter-i/2.1·annex-ix/chapter-ii·annex-vii/4.5.2·annex-vii/4.5.4·annex-xiii/part-b·chapter-i/section-1/article-2·chapter-ii/article-10/8·chapter-viii/article-100/2·chapter-viii/article-99;eu-machinery-regulationchapter-i/article-3·chapter-ii/article-13/2·chapter-v/article-40/1;eu-mdrannex-ix/chapter-i/2.1·annex-ix/chapter-ii·annex-vii/4.5.2·annex-vii/4.5.5·annex-xiv/part-b·chapter-i/article-2·chapter-ii/article-10/9·chapter-viii/article-105 - conformity assessment body 7 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3·chapter-iv/article-39/10;eu-cybersecurity-acttitle-iv/article-69/2;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2 - conformity self-assessment 1 clause:
eu-cybersecurity-acttitle-iii/article-58/7 - consumer 3 clauses:
eu-ai-actchapter-vii/section-1/article-66·chapter-xiii/article-113;eu-cyber-resilience-actchapter-i/article-3 - control material 1 clause:
eu-ivdrchapter-i/section-1/article-2 - corrective action 17 clauses:
eu-ai-actchapter-iii/section-3/article-20/2·chapter-ix/section-3/article-79/5·chapter-ix/section-3/article-80/2·chapter-ix/section-3/article-82/2;eu-cyber-resilience-actchapter-v/article-52/3·chapter-v/article-54/5·chapter-v/article-57/2;eu-ivdrannex-vii/4.10·chapter-i/section-1/article-2·chapter-vii/section-1/article-78/3·chapter-vii/section-1/article-78/4;eu-machinery-regulationchapter-vi/article-43/1·chapter-vi/article-43/4;eu-mdrannex-vii/4.10·chapter-i/article-2·chapter-vii/section-1/article-83/3·chapter-vii/section-1/article-83/4 - critical infrastructure 1 clause:
eu-ai-actchapter-i/article-3 - CSIRT designated as coordinator 2 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-v/article-52/5 - custom-made device 1 clause:
eu-mdrchapter-i/article-2 - cyber threat 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - cybersecurity 29 clauses:
eu-ai-actchapter-vii/section-1/article-66·chapter-xiii/article-113;eu-cyber-resilience-actannex-vii·chapter-i/article-1·chapter-i/article-10·chapter-i/article-3·chapter-ii/article-13/22·chapter-ii/article-13/8·chapter-ii/article-19/3·chapter-ii/article-19/5·chapter-ii/article-19/7·chapter-ii/article-20/3·chapter-ii/article-20/4·chapter-ii/article-20/5·chapter-ii/article-24/2·chapter-v/article-52/4·chapter-v/article-52/8·chapter-v/article-53·chapter-v/article-54/1·chapter-v/article-54/2·chapter-v/article-54/6·chapter-v/article-56/1·chapter-v/article-56/2·chapter-v/article-57/1·chapter-viii/article-71/2;eu-cybersecurity-acttitle-iii/article-58/7·title-iv/article-69/2;eu-digital-omnibus-aiarticle-4;eu-machinery-regulationchapter-ix/article-54 - cybersecurity risk 10 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-19/3·chapter-ii/article-19/5·chapter-ii/article-20/3·chapter-ii/article-20/4·chapter-v/article-54/1·chapter-v/article-54/2·chapter-v/article-56/1·chapter-v/article-56/2·chapter-v/article-57/1 - deep fake 1 clause:
eu-ai-actchapter-i/article-3 - deployer 10 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-20/2·chapter-iii/section-3/article-26/10·chapter-iii/section-3/article-26/5·chapter-iii/section-3/article-27/3·chapter-ix/section-3/article-76/3·chapter-ix/section-3/article-78/3·chapter-vi/article-60/4;eu-digital-omnibus-aiarticle-1/6·article-1/9 - derivative 3 clauses:
eu-mdrannex-ix/chapter-ii·annex-xi/part-b·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 1 clause:
eu-ivdrchapter-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 10 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-26/5;eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-20/3·chapter-ii/article-20/6;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3·chapter-ii/article-15/3·chapter-ii/article-16/3;eu-mdrchapter-i/article-2 - downstream provider 1 clause:
eu-ai-actchapter-i/article-3 - economic operator 17 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-23/1·chapter-v/article-53·chapter-v/article-54/1·chapter-v/article-54/3·chapter-v/article-54/5·chapter-v/article-54/6·chapter-v/article-57/1·chapter-vii/article-64/5;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3·chapter-ii/article-19/1·chapter-vi/article-43/1·chapter-vi/article-43/2·chapter-vi/article-43/4·chapter-vi/article-43/5;eu-mdrchapter-i/article-2 - electronic information system 2 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-v/article-57/1 - emotion recognition system 1 clause:
eu-ai-actchapter-i/article-3 - end-point 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - entity 1 clause:
eu-ai-actchapter-i/article-3 - essential health and safety requirements 8 clauses:
eu-machinery-regulationchapter-i/article-3·chapter-i/article-6/7·chapter-ii/article-10/3·chapter-ii/article-11/3·chapter-ii/article-13/8·chapter-ii/article-14/2·chapter-ii/article-16/3·chapter-vi/article-43/5 - ethics committee 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - European cybersecurity certification scheme 1 clause:
eu-cybersecurity-acttitle-iii/article-58/7 - European standard 3 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - exploitable vulnerability 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - falsified device 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - field safety corrective action 6 clauses:
eu-ivdrchapter-i/section-1/article-2·chapter-vii/section-1/article-78/3·chapter-vii/section-1/article-78/4;eu-mdrchapter-i/article-2·chapter-vii/section-1/article-83/3·chapter-vii/section-1/article-83/4 - field safety notice 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - floating-point operation 1 clause:
eu-ai-actchapter-i/article-3 - free and open-source software 3 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-13/25·chapter-ii/article-24/2 - fully refurbishing 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - general-purpose AI model 3 clauses:
eu-ai-actchapter-i/article-3·chapter-ix/section-3/article-75/1·chapter-ix/section-3/article-75/3 - general-purpose AI system 1 clause:
eu-ai-actchapter-i/article-3 - generic device group 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - guard 1 clause:
eu-machinery-regulationchapter-i/article-3 - hardware 2 clauses:
eu-cyber-resilience-actannex-vii·chapter-i/article-3 - harmonised standard 6 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-5/article-43/1;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2 - Hazard / hazard 1 clause:
eu-machinery-regulationchapter-i/article-3 - health institution 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - high-impact capabilities 1 clause:
eu-ai-actchapter-i/article-3 - implantable device 1 clause:
eu-mdrchapter-i/article-2 - importer 13 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-23/2·chapter-iii/section-3/article-26/5;eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-19/3·chapter-ii/article-19/8;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3·chapter-ii/article-13/2·chapter-ii/article-14/2·chapter-ii/article-15/3·chapter-ii/article-16/3;eu-mdrchapter-i/article-2 - in vitro diagnostic medical device 1 clause:
eu-ivdrchapter-i/section-1/article-2 - incident 15 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-26/5·chapter-ix/section-2/article-73/1·chapter-ix/section-2/article-73/7·chapter-ix/section-3/article-76/3·chapter-vi/article-60/7·chapter-vii/section-1/article-66;eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-16/3;eu-ivdrchapter-i/section-1/article-2·chapter-vii/section-1/article-78/4·chapter-vii/section-2/article-86;eu-mdrchapter-i/article-2·chapter-vii/section-1/article-83/4·chapter-vii/section-2/article-91 - indirect connection 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - informed consent 4 clauses:
eu-ai-actchapter-i/article-3·chapter-vi/article-60/4;eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - input data 1 clause:
eu-ai-actchapter-i/article-3 - instructions for use 14 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-26/5·chapter-vi/article-60/4;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrannex-ix/chapter-ii·annex-vii/4.10·chapter-i/section-1/article-2·chapter-vii/section-1/article-78/3;eu-machinery-regulationchapter-i/article-3;eu-mdrannex-ix/chapter-ii·annex-vii/4.10·chapter-i/article-2·chapter-vii/section-1/article-83/3·chapter-x/article-123/3 - intended purpose 13 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actannex-vii·chapter-i/article-3·chapter-ii/article-13/8;eu-ivdrannex-ix/chapter-ii·annex-xiii/part-b·chapter-i/section-1/article-2·chapter-x/article-110/3;eu-machinery-regulationchapter-i/article-3;eu-mdrannex-ix/chapter-ii·annex-xiv/part-b·chapter-i/article-2·chapter-x/article-120/3 - intended use 8 clauses:
eu-ivdrannex-i/chapter-i/3·annex-ix/chapter-ii·annex-vii/4.5.2·annex-vii/4.5.4;eu-machinery-regulationchapter-i/article-6/5;eu-mdrannex-i/chapter-i/3·annex-vii/4.5.2·annex-vii/4.5.5 - interchangeable equipment 1 clause:
eu-machinery-regulationchapter-i/article-3 - international standard 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - interventional clinical performance study 1 clause:
eu-ivdrchapter-i/section-1/article-2 - invasive device 1 clause:
eu-mdrchapter-i/article-2 - investigational device 1 clause:
eu-mdrchapter-i/article-2 - investigator 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - kit 1 clause:
eu-ivdrchapter-i/section-1/article-2 - label 4 clauses:
eu-ivdrannex-ix/chapter-ii·chapter-i/section-1/article-2;eu-mdrannex-xiv/part-b·chapter-i/article-2 - law enforcement 10 clauses:
eu-ai-actchapter-i/article-3·chapter-ii/article-5/4·chapter-ii/article-5/6·chapter-iii/section-3/article-26/10·chapter-iii/section-3/article-26/5·chapter-iii/section-5/article-43/1·chapter-ix/section-3/article-74/8·chapter-ix/section-3/article-78/3·chapter-vi/article-60/4;eu-digital-omnibus-aiarticle-1/6 - law enforcement authority 1 clause:
eu-ai-actchapter-i/article-3 - lay person 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - lifetime 10 clauses:
eu-cyber-resilience-actchapter-ii/article-13/8;eu-ivdrannex-xiii/part-b·chapter-i/section-1/article-2·chapter-vii/section-1/article-78/2·chapter-vii/section-1/article-81/1;eu-machinery-regulationchapter-i/article-3;eu-mdrannex-xiv/part-b·chapter-i/article-2·chapter-vii/section-1/article-83/2·chapter-vii/section-1/article-86/1 - lifting accessory 1 clause:
eu-machinery-regulationchapter-i/article-3 - likelihood ratio 1 clause:
eu-ivdrchapter-i/section-1/article-2 - logical connection 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - machinery 23 clauses:
eu-ai-actchapter-xiii/article-113;eu-cyber-resilience-actchapter-viii/article-71/2;eu-digital-omnibus-aiarticle-1/9·article-4;eu-ivdrchapter-x/article-113/3;eu-machinery-regulationchapter-i/article-3·chapter-i/article-6/5·chapter-i/article-6/7·chapter-ii/article-10/3·chapter-ii/article-10/6·chapter-ii/article-11/3·chapter-ii/article-11/6·chapter-ii/article-12/2·chapter-ii/article-13/2·chapter-ii/article-13/3·chapter-ii/article-13/8·chapter-ii/article-14/2·chapter-ii/article-14/3·chapter-ii/article-14/7·chapter-ii/article-15/3·chapter-ii/article-16/3·chapter-ix/article-54;eu-mdrchapter-x/article-123/3 - making available on the market 9 clauses:
eu-ai-actchapter-i/article-3·chapter-xiii/article-113;eu-cyber-resilience-actchapter-i/article-1·chapter-i/article-3·chapter-viii/article-71/2;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3·chapter-ix/article-54;eu-mdrchapter-i/article-2 - manufacturer 73 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actannex-vii·chapter-i/article-3·chapter-ii/article-13/16·chapter-ii/article-13/22·chapter-ii/article-13/23·chapter-ii/article-18/3·chapter-ii/article-19/2·chapter-ii/article-19/3·chapter-ii/article-19/5·chapter-ii/article-19/7·chapter-ii/article-19/8·chapter-ii/article-20/3·chapter-ii/article-20/4·chapter-ii/article-20/5·chapter-ii/article-20/6·chapter-v/article-52/16·chapter-v/article-54/6·chapter-v/article-57/1·chapter-v/article-57/2·chapter-v/article-58/1;eu-ivdrannex-iii·annex-iii/1·annex-ix/chapter-i/2.1·annex-ix/chapter-i/3.2·annex-ix/chapter-i/3.3·annex-ix/chapter-ii·annex-vii/4.10·annex-vii/4.11·annex-vii/4.5.2·annex-vii/4.5.4·annex-vii/4.8·annex-xiii/part-a/1.3.3·annex-xiii/part-b·chapter-i/section-1/article-2·chapter-ii/article-10/8·chapter-iv/article-42/6·chapter-vi/article-56/6·chapter-vii/section-1/article-78·chapter-vii/section-1/article-78/1·chapter-vii/section-1/article-78/3·chapter-vii/section-1/article-78/4·chapter-vii/section-2/article-83/1·chapter-viii/article-100/2;eu-machinery-regulationchapter-i/article-3·chapter-i/article-6/7·chapter-ii/article-10/6·chapter-ii/article-11/6·chapter-ii/article-12/2·chapter-ii/article-13/2·chapter-ii/article-14/2·chapter-ii/article-15/3·chapter-ii/article-16/3;eu-mdrannex-iii·annex-ix/chapter-i/2.1·annex-ix/chapter-i/3.2·annex-ix/chapter-i/3.3·annex-ix/chapter-ii·annex-vii/4.10·annex-vii/4.11·annex-vii/4.5.2·annex-vii/4.5.5·annex-vii/4.8·annex-xi/part-b·annex-xiv/part-b·chapter-i/article-2·chapter-ii/article-10/9·chapter-vi/article-61/11·chapter-vii/section-1/article-83·chapter-vii/section-1/article-83/1·chapter-vii/section-1/article-83/3·chapter-vii/section-1/article-83/4·chapter-vii/section-2/article-88/1 - market surveillance authority 71 clauses:
eu-ai-actchapter-i/article-3·chapter-ii/article-5/4·chapter-iii/section-3/article-22/4·chapter-iii/section-3/article-26/10·chapter-iii/section-3/article-26/5·chapter-iii/section-3/article-27/3·chapter-iii/section-5/article-43/1·chapter-iii/section-5/article-46/1·chapter-iii/section-5/article-46/3·chapter-iii/section-5/article-46/4·chapter-iii/section-5/article-46/5·chapter-iii/section-5/article-46/6·chapter-ix/section-2/article-73/7·chapter-ix/section-2/article-73/8·chapter-ix/section-3/article-74/3·chapter-ix/section-3/article-74/6·chapter-ix/section-3/article-74/7·chapter-ix/section-3/article-74/9·chapter-ix/section-3/article-75/1·chapter-ix/section-3/article-75/3·chapter-ix/section-3/article-76/3·chapter-ix/section-3/article-76/4·chapter-ix/section-3/article-76/5·chapter-ix/section-3/article-77/1·chapter-ix/section-3/article-77/3·chapter-ix/section-3/article-78/3·chapter-ix/section-3/article-79/2·chapter-ix/section-3/article-79/3·chapter-ix/section-3/article-79/5·chapter-ix/section-3/article-79/7·chapter-ix/section-3/article-79/8·chapter-ix/section-3/article-80/1·chapter-ix/section-3/article-80/2·chapter-ix/section-3/article-80/3·chapter-ix/section-3/article-80/7·chapter-ix/section-3/article-81/1·chapter-ix/section-3/article-82/1·chapter-ix/section-3/article-82/2·chapter-ix/section-3/article-83/1·chapter-ix/section-3/article-83/2·chapter-ix/section-4/article-85·chapter-vi/article-60/4·chapter-vi/article-60/7·chapter-vi/article-60/8·chapter-vii/section-2/article-70/1·chapter-vii/section-2/article-70/2;eu-cyber-resilience-actannex-vii·chapter-i/article-3·chapter-ii/article-13/22·chapter-ii/article-18/3·chapter-ii/article-19/7·chapter-ii/article-20/5·chapter-ii/article-24/2·chapter-v/article-52/2·chapter-v/article-52/3·chapter-v/article-54/1·chapter-v/article-54/2·chapter-v/article-54/3·chapter-v/article-54/5·chapter-v/article-54/6·chapter-v/article-54/7·chapter-v/article-57/1·chapter-v/article-57/2·chapter-v/article-57/6·chapter-v/article-58/1·chapter-v/article-59/4·chapter-v/article-59/5·chapter-vii/article-63/2;eu-digital-omnibus-aiarticle-1/6·article-1/9;eu-machinery-regulationchapter-i/article-3 - medical device 3 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2·chapter-vi/article-61/9 - nanomaterial 2 clauses:
eu-mdrchapter-i/article-2·chapter-x/article-123/3 - national accreditation body 1 clause:
eu-machinery-regulationchapter-i/article-3 - national competent authority 6 clauses:
eu-ai-actchapter-i/article-3·chapter-ix/section-3/article-78/3·chapter-vi/article-57/7;eu-digital-omnibus-aiarticle-1/6·article-1/9;eu-ivdrchapter-iv/article-42/6 - near miss 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - negative predictive value 1 clause:
eu-ivdrchapter-i/section-1/article-2 - non-personal data 1 clause:
eu-ai-actchapter-i/article-3 - non-viable 2 clauses:
eu-mdrannex-ix/chapter-ii·chapter-i/article-2 - notified body 50 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-20/2·chapter-iii/section-3/article-22/3·chapter-iii/section-3/article-22/4·chapter-iii/section-4/article-36/6·chapter-iii/section-5/article-43/1·chapter-ix/section-3/article-79/2;eu-cyber-resilience-actchapter-i/article-3·chapter-iv/article-45/2·chapter-v/article-54/1·chapter-v/article-58/1;eu-digital-omnibus-aiarticle-1/6;eu-ivdrannex-ix/chapter-i/2.1·annex-ix/chapter-i/3.2·annex-ix/chapter-i/3.3·annex-ix/chapter-ii·annex-vii/4.10·annex-vii/4.11·annex-vii/4.5.2·annex-vii/4.5.4·annex-vii/4.8·chapter-i/section-1/article-2·chapter-iv/article-40/6·chapter-iv/article-41/5·chapter-iv/article-42/6·chapter-vii/section-1/article-78/4·chapter-vii/section-1/article-80·chapter-x/article-110/3·chapter-x/article-113/3;eu-machinery-regulationchapter-i/article-3·chapter-v/article-36/2·chapter-v/article-40/1·chapter-vi/article-43/1;eu-mdrannex-ix/chapter-i/2.1·annex-ix/chapter-i/3.2·annex-ix/chapter-i/3.3·annex-ix/chapter-ii·annex-vii/4.10·annex-vii/4.11·annex-vii/4.5.2·annex-vii/4.5.5·annex-vii/4.8·annex-xi/part-b·chapter-i/article-2·chapter-iv/article-44/6·chapter-iv/article-45/5·chapter-iv/article-46/6·chapter-vii/section-1/article-83/4·chapter-x/article-120/3·chapter-x/article-123/3 - notifying authority 8 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-4/article-36/6·chapter-iii/section-5/article-45/1·chapter-vii/section-2/article-70/1;eu-cyber-resilience-actchapter-i/article-3·chapter-iv/article-49/1;eu-machinery-regulationchapter-v/article-36/2·chapter-v/article-40/1 - online search engine 1 clause:
eu-digital-omnibus-aiarticle-1/6 - open-source software steward 2 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-v/article-52/3 - operator 29 clauses:
eu-ai-actchapter-i/article-3·chapter-ix/section-3/article-79/2·chapter-ix/section-3/article-79/3·chapter-ix/section-3/article-79/5·chapter-ix/section-3/article-79/6·chapter-ix/section-3/article-79/8·chapter-ix/section-3/article-81/1·chapter-ix/section-3/article-82/1·chapter-ix/section-3/article-82/2·chapter-xii/article-99/7;eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-23/1·chapter-v/article-53·chapter-v/article-54/1·chapter-v/article-54/3·chapter-v/article-54/5·chapter-v/article-54/6·chapter-v/article-57/1·chapter-vii/article-64/5;eu-digital-omnibus-aiarticle-1/6·article-1/9;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3·chapter-ii/article-19/1·chapter-vi/article-43/1·chapter-vi/article-43/2·chapter-vi/article-43/4·chapter-vi/article-43/5;eu-mdrchapter-i/article-2 - particle 1 clause:
eu-mdrchapter-i/article-2 - partly completed machinery 8 clauses:
eu-machinery-regulationchapter-i/article-3·chapter-ii/article-11/3·chapter-ii/article-11/6·chapter-ii/article-12/2·chapter-ii/article-14/2·chapter-ii/article-14/3·chapter-ii/article-14/7·chapter-ii/article-16/3 - performance 42 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-v/article-60/3;eu-digital-omnibus-aiarticle-1/6;eu-ivdrannex-iii/1·annex-ix/chapter-i/2.1·annex-ix/chapter-ii·annex-vii/4.10·annex-vii/4.11·annex-vii/4.5.2·annex-vii/4.5.4·annex-vii/4.8·annex-xiii/part-a/1.3.3·annex-xiii/part-b·chapter-i/section-1/article-2·chapter-ii/article-10/8·chapter-ii/article-15/3·chapter-ii/article-8/1·chapter-iii/article-30/2·chapter-iv/article-41/5·chapter-vi/article-56/6·chapter-vii/section-1/article-78/2·chapter-vii/section-1/article-78/3·chapter-vii/section-2/article-83/1·chapter-viii/article-100/2·chapter-viii/article-99·chapter-x/article-113/3;eu-mdrannex-iii·annex-ix/chapter-ii·annex-vii/4.10·annex-vii/4.11·annex-vii/4.5.2·annex-vii/4.5.5·annex-xiv/part-b·chapter-i/article-2·chapter-ii/article-10/9·chapter-iv/article-45/5·chapter-vi/article-61/11·chapter-vi/article-61/9·chapter-vii/section-1/article-83/2·chapter-vii/section-1/article-83/3·chapter-viii/article-105·chapter-x/article-123/3 - performance evaluation 14 clauses:
eu-ivdrannex-ix/chapter-i/2.1·annex-ix/chapter-ii·annex-vii/4.10·annex-vii/4.11·annex-vii/4.5.2·annex-vii/4.5.4·annex-vii/4.8·annex-xiii/part-a/1.3.3·annex-xiii/part-b·chapter-i/section-1/article-2·chapter-ii/article-10/8·chapter-iv/article-41/5·chapter-vi/article-56/6·chapter-vii/section-1/article-78/3 - performance of a device 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - performance of an AI system 1 clause:
eu-ai-actchapter-i/article-3 - performance study 3 clauses:
eu-ivdrannex-vii/4.5.4·chapter-i/section-1/article-2·chapter-ii/article-10/8 - performance study plan 2 clauses:
eu-ivdrannex-vii/4.5.4·chapter-i/section-1/article-2 - personal data 12 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-26/10·chapter-vi/article-60/4·chapter-xiii/article-113;eu-cyber-resilience-actchapter-i/article-3·chapter-v/article-52/7·chapter-viii/article-71/2;eu-cybersecurity-acttitle-iv/article-69/2;eu-digital-omnibus-aiarticle-1/6·article-4;eu-ivdrchapter-x/article-113/3;eu-mdrchapter-x/article-123/3 - physical connection 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - placing on the market 10 clauses:
eu-ai-actchapter-i/article-1/2·chapter-i/article-3·chapter-iii/section-5/article-46/1·chapter-ix/section-3/article-74/6;eu-cyber-resilience-actchapter-i/article-3·chapter-iii/article-33/2;eu-digital-omnibus-aiarticle-1/6;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2 - positive predictive value 1 clause:
eu-ivdrchapter-i/section-1/article-2 - post-market monitoring system 2 clauses:
eu-ai-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/6 - post-market surveillance 71 clauses:
eu-ivdrannex-i/chapter-i/3·annex-iii·annex-iii/1·annex-iii/2·annex-ix/chapter-i/2.1·annex-ix/chapter-i/3.2·annex-ix/chapter-i/3.3·annex-ix/chapter-ii·annex-vii/4.10·annex-vii/4.11·annex-vii/4.5.2·annex-vii/4.5.4·annex-vii/4.8·annex-xiii/part-a/1.3.3·annex-xiii/part-b·chapter-i/section-1/article-2·chapter-ii/article-10/8·chapter-ii/article-10/9·chapter-ii/article-15/3·chapter-ii/article-8/1·chapter-iii/article-30/2·chapter-iv/article-40/6·chapter-iv/article-41/5·chapter-vi/article-56/6·chapter-vii/section-1/article-78/1·chapter-vii/section-1/article-78/2·chapter-vii/section-1/article-78/3·chapter-vii/section-1/article-78/4·chapter-vii/section-1/article-79·chapter-vii/section-1/article-80·chapter-vii/section-1/article-81/1·chapter-vii/section-2/article-83/1·chapter-vii/section-2/article-86·chapter-vii/section-2/article-87·chapter-x/article-110/3·chapter-x/article-113/3;eu-mdrannex-i/chapter-i/3·annex-iii·annex-ix/chapter-i/2.1·annex-ix/chapter-i/3.2·annex-ix/chapter-i/3.3·annex-ix/chapter-ii·annex-vii/4.10·annex-vii/4.11·annex-vii/4.5.2·annex-vii/4.5.5·annex-vii/4.8·annex-xi/part-b·annex-xiv/part-b·chapter-i/article-2·chapter-ii/article-10/10·chapter-ii/article-10/9·chapter-ii/article-15/3·chapter-ii/article-8/1·chapter-iii/article-33/2·chapter-iv/article-44/6·chapter-iv/article-45/5·chapter-vi/article-61/11·chapter-vi/article-61/9·chapter-vii/section-1/article-83/1·chapter-vii/section-1/article-83/2·chapter-vii/section-1/article-83/3·chapter-vii/section-1/article-83/4·chapter-vii/section-1/article-84·chapter-vii/section-1/article-85·chapter-vii/section-1/article-86/1·chapter-vii/section-2/article-88/1·chapter-vii/section-2/article-91·chapter-vii/section-2/article-92·chapter-x/article-120/3·chapter-x/article-123/3 - post-remote biometric identification system 2 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-26/10 - predictive value 1 clause:
eu-ivdrchapter-i/section-1/article-2 - procedure pack 1 clause:
eu-mdrchapter-i/article-2 - product with digital elements 34 clauses:
eu-cyber-resilience-actannex-vii·chapter-i/article-3·chapter-ii/article-13/13·chapter-ii/article-13/16·chapter-ii/article-13/18·chapter-ii/article-13/22·chapter-ii/article-13/8·chapter-ii/article-16/3·chapter-ii/article-18/3·chapter-ii/article-19/2·chapter-ii/article-19/3·chapter-ii/article-19/4·chapter-ii/article-19/5·chapter-ii/article-19/6·chapter-ii/article-19/7·chapter-ii/article-19/8·chapter-ii/article-20/3·chapter-ii/article-20/4·chapter-ii/article-20/5·chapter-ii/article-20/6·chapter-ii/article-23/1·chapter-ii/article-24/2·chapter-v/article-54/1·chapter-v/article-54/2·chapter-v/article-54/5·chapter-v/article-54/6·chapter-v/article-54/7·chapter-v/article-54/9·chapter-v/article-56/1·chapter-v/article-56/2·chapter-v/article-56/3·chapter-v/article-57/1·chapter-v/article-57/6·chapter-v/article-57/7 - professional user 2 clauses:
eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2 - profiling 1 clause:
eu-ai-actchapter-i/article-3 - provider 23 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-20/2·chapter-iii/section-3/article-22/3·chapter-iii/section-3/article-22/4·chapter-iii/section-3/article-23/2·chapter-iii/section-3/article-26/5·chapter-iii/section-5/article-43/1·chapter-ix/section-3/article-75/1·chapter-ix/section-3/article-76/2·chapter-ix/section-3/article-76/3·chapter-ix/section-3/article-76/4·chapter-ix/section-3/article-80/1·chapter-ix/section-3/article-80/2·chapter-ix/section-3/article-80/3·chapter-ix/section-3/article-80/7·chapter-ix/section-3/article-82/2·chapter-ix/section-3/article-83/1·chapter-vi/article-57/7·chapter-vi/article-60/4·chapter-vi/article-60/7·chapter-viii/article-71/4;eu-digital-omnibus-aiarticle-1/6·article-1/9 - publicly accessible space 1 clause:
eu-ai-actchapter-i/article-3 - putting into service 8 clauses:
eu-ai-actchapter-i/article-1/2·chapter-i/article-3·chapter-iii/section-5/article-46/1·chapter-ix/section-3/article-74/6;eu-digital-omnibus-aiarticle-1/6;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2 - Quality 2 clauses:
eu-ivdrannex-vii/4.5.2;eu-mdrannex-vii/4.5.2 - real-time remote biometric identification system 1 clause:
eu-ai-actchapter-i/article-3 - real-world testing plan 3 clauses:
eu-ai-actchapter-i/article-3·chapter-vi/article-60/4;eu-digital-omnibus-aiarticle-1/6 - reasonably foreseeable misuse 5 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrannex-i/chapter-i/3;eu-machinery-regulationchapter-i/article-6/5;eu-mdrannex-i/chapter-i/3 - reasonably foreseeable use 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - recall 13 clauses:
eu-ai-actchapter-i/article-3·chapter-ix/section-3/article-79/2·chapter-ix/section-3/article-79/5·chapter-vi/article-60/7;eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-19/5·chapter-ii/article-20/4·chapter-v/article-54/1·chapter-v/article-54/5;eu-digital-omnibus-aiarticle-1/6;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2 - recall of an AI system 1 clause:
eu-ai-actchapter-i/article-3 - remote biometric identification system 3 clauses:
eu-ai-actchapter-i/article-3·chapter-ii/article-5/4·chapter-iii/section-3/article-26/10 - remote data processing 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - removable mechanical transmission device 1 clause:
eu-machinery-regulationchapter-i/article-3 - representative 20 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-22/3·chapter-iii/section-3/article-22/4·chapter-iii/section-3/article-23/2·chapter-ix/section-3/article-83/1·chapter-vi/article-60/4·chapter-xiii/article-113;eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-18/3·chapter-viii/article-71/2;eu-digital-omnibus-aiarticle-1/6;eu-ivdrannex-ix/chapter-i/2.1·annex-ix/chapter-i/3.2·chapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3·chapter-ii/article-12/2;eu-mdrannex-ix/chapter-i/2.1·annex-ix/chapter-i/3.2·annex-xi/part-b·chapter-i/article-2 - reprocessing 1 clause:
eu-mdrchapter-i/article-2 - Requirements 3 clauses:
ema-pics-annex15-concept1;eu-ivdrchapter-x/article-113/3;eu-mdrchapter-x/article-123/3 - Risk / risk 93 clauses:
ema-pics-annex15-concept1;eu-ai-actchapter-i/article-1/2·chapter-i/article-3·chapter-iii/section-3/article-20/2·chapter-iii/section-3/article-22/3·chapter-iii/section-3/article-23/2·chapter-iii/section-3/article-26/10·chapter-iii/section-3/article-26/5·chapter-iii/section-5/article-43/1·chapter-iii/section-5/article-46/1·chapter-iii/section-5/article-46/3·chapter-ix/section-2/article-73/1·chapter-ix/section-3/article-74/10·chapter-ix/section-3/article-74/11·chapter-ix/section-3/article-74/12·chapter-ix/section-3/article-74/3·chapter-ix/section-3/article-74/6·chapter-ix/section-3/article-74/8·chapter-ix/section-3/article-75/2·chapter-ix/section-3/article-75/3·chapter-ix/section-3/article-77/1·chapter-ix/section-3/article-77/3·chapter-ix/section-3/article-78/3·chapter-ix/section-3/article-79/2·chapter-ix/section-3/article-79/6·chapter-ix/section-3/article-80/1·chapter-ix/section-3/article-80/2·chapter-ix/section-3/article-80/7·chapter-ix/section-3/article-82/1·chapter-ix/section-3/article-83/2·chapter-vi/article-60/4·chapter-vi/article-60/6·chapter-vii/section-1/article-68/3;eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-19/3·chapter-ii/article-19/5·chapter-ii/article-20/3·chapter-ii/article-20/4·chapter-v/article-52/14·chapter-v/article-54/1·chapter-v/article-54/2·chapter-v/article-54/6·chapter-v/article-56/1·chapter-v/article-56/2·chapter-v/article-57/1;eu-digital-omnibus-aiarticle-1/6·article-1/9;eu-ivdrannex-i/chapter-i/3·annex-iii/1·annex-ix/chapter-i/3.2·annex-ix/chapter-ii·annex-vii/4.10·annex-vii/4.11·annex-vii/4.5.4·annex-vii/4.8·annex-xiii/part-b·chapter-i/section-1/article-2·chapter-ii/article-10/8·chapter-ii/article-8/1·chapter-iv/article-42/6·chapter-vii/section-1/article-78/1·chapter-vii/section-1/article-78/3·chapter-vii/section-1/article-81/1·chapter-vii/section-2/article-83/1·chapter-vii/section-3/article-89·chapter-vii/section-3/article-95/1;eu-machinery-regulationchapter-i/article-3·chapter-i/article-6/7·chapter-ii/article-13/2·chapter-ii/article-14/2·chapter-ii/article-15/3·chapter-ii/article-16/3·chapter-vi/article-43/1·chapter-vi/article-43/4·chapter-vi/article-43/5;eu-mdrannex-i/chapter-i/3·annex-iii·annex-ix/chapter-i/3.2·annex-ix/chapter-ii·annex-vii/4.10·annex-vii/4.11·annex-vii/4.5.5·annex-vii/4.8·annex-xiv/part-b·chapter-i/article-2·chapter-ii/article-10/9·chapter-ii/article-8/1·chapter-vii/section-1/article-83/1·chapter-vii/section-1/article-83/3·chapter-vii/section-1/article-86/1·chapter-vii/section-2/article-88/1·chapter-vii/section-3/article-100/1·chapter-vii/section-3/article-94 - ropes 2 clauses:
eu-machinery-regulationchapter-i/article-3·chapter-ix/article-54 - safety component 2 clauses:
eu-ai-actchapter-i/article-3;eu-machinery-regulationchapter-i/article-3 - safety function 2 clauses:
eu-ai-actchapter-i/article-3;eu-machinery-regulationchapter-i/article-3 - sandbox plan 2 clauses:
eu-ai-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/6 - scientific validity of an analyte 1 clause:
eu-ivdrchapter-i/section-1/article-2 - security of network and information systems 1 clause:
eu-cybersecurity-acttitle-iv/article-69/2 - sensitive operational data 5 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-26/10·chapter-iii/section-3/article-26/5·chapter-iii/section-5/article-46/3·chapter-ix/section-3/article-78/3 - serious adverse event 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - serious incident 11 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-26/5·chapter-ix/section-2/article-73/1·chapter-ix/section-2/article-73/7·chapter-ix/section-3/article-76/3·chapter-vi/article-60/7·chapter-vii/section-1/article-66;eu-ivdrchapter-i/section-1/article-2·chapter-vii/section-1/article-78/4;eu-mdrchapter-i/article-2·chapter-vii/section-1/article-83/4 - serious public health threat 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - significant cybersecurity risk 10 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-19/3·chapter-ii/article-19/5·chapter-ii/article-20/3·chapter-ii/article-20/4·chapter-v/article-54/1·chapter-v/article-54/2·chapter-v/article-56/1·chapter-v/article-56/2·chapter-v/article-57/1 - single-use device 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - software 9 clauses:
eu-cyber-resilience-actannex-vii·chapter-i/article-3·chapter-ii/article-13/25·chapter-ii/article-24/2·chapter-v/article-52/15·chapter-v/article-52/3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2 - software bill of materials 2 clauses:
eu-cyber-resilience-actannex-vii·chapter-i/article-3 - source code 6 clauses:
eu-ai-actchapter-ix/section-3/article-78/1;eu-cyber-resilience-actchapter-i/article-3;eu-machinery-regulationchapter-i/article-3·chapter-ii/article-10/3·chapter-ii/article-11/3·chapter-ii/article-13/8 - special categories of personal data 1 clause:
eu-ai-actchapter-i/article-3 - specimen receptacle 1 clause:
eu-ivdrchapter-i/section-1/article-2 - sponsor 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - standard 9 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-5/article-43/1;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2·chapter-vii/section-2/article-86;eu-machinery-regulationchapter-i/article-3;eu-mdrannex-xi/part-b·chapter-i/article-2·chapter-vii/section-2/article-91 - subject 17 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-26/10·chapter-iii/section-3/article-26/5·chapter-ix/section-3/article-74/12·chapter-ix/section-3/article-80/7·chapter-vi/article-60/4·chapter-vii/section-1/article-66;eu-cyber-resilience-actchapter-i/article-3·chapter-vii/article-64/4;eu-cybersecurity-acttitle-iii/article-58/7;eu-digital-omnibus-aiarticle-1/6·article-1/9;eu-ivdrannex-iii/1·chapter-i/section-1/article-2;eu-mdrannex-iii·annex-xi/part-b·chapter-i/article-2 - substantial modification 3 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-machinery-regulationchapter-i/article-3 - Supervisor 3 clauses:
eu-ai-actchapter-i/article-3·chapter-ix/section-3/article-74/9;eu-digital-omnibus-aiarticle-1/6 - support period 8 clauses:
eu-cyber-resilience-actannex-vii·chapter-i/article-3·chapter-ii/article-13/13·chapter-ii/article-13/18·chapter-ii/article-13/8·chapter-ii/article-18/3·chapter-ii/article-19/6·chapter-v/article-52/16 - System / system 93 clauses:
eu-ai-actchapter-i/article-3·chapter-ii/article-5/4·chapter-iii/section-3/article-20/2·chapter-iii/section-3/article-22/3·chapter-iii/section-3/article-23/2·chapter-iii/section-3/article-26/10·chapter-iii/section-3/article-26/5·chapter-iii/section-5/article-43/1·chapter-iii/section-5/article-45/1·chapter-iii/section-5/article-46/3·chapter-iii/section-5/article-46/5·chapter-ix/section-3/article-74/6·chapter-ix/section-3/article-75/1·chapter-ix/section-3/article-75/3·chapter-ix/section-3/article-76/5·chapter-ix/section-3/article-77/3·chapter-ix/section-3/article-79/2·chapter-ix/section-3/article-79/5·chapter-ix/section-3/article-79/6·chapter-ix/section-3/article-79/7·chapter-ix/section-3/article-79/9·chapter-ix/section-3/article-80/1·chapter-ix/section-3/article-80/2·chapter-ix/section-3/article-80/3·chapter-ix/section-3/article-80/7·chapter-ix/section-3/article-82/1·chapter-ix/section-3/article-83/2·chapter-vi/article-57/7·chapter-vi/article-60/4·chapter-vi/article-60/7·chapter-xii/article-99/7·chapter-xiii/article-113;eu-cyber-resilience-actannex-vii·chapter-i/article-3·chapter-v/article-57/1·chapter-vii/article-64/6;eu-digital-omnibus-aiarticle-1/6;eu-ivdrannex-i/chapter-i/3·annex-ix/chapter-i/2.1·annex-ix/chapter-i/3.2·annex-ix/chapter-i/3.3·annex-ix/chapter-ii·annex-vii/4.10·annex-vii/4.5.2·annex-vii/4.8·annex-xiii/part-a/1.3.3·chapter-i/section-1/article-2·chapter-ii/article-10/8·chapter-ii/article-10/9·chapter-ii/article-15/3·chapter-ii/article-8/1·chapter-iii/article-30/2·chapter-iv/article-42/6·chapter-vii/section-1/article-78·chapter-vii/section-1/article-78/1·chapter-vii/section-1/article-78/2·chapter-vii/section-1/article-78/3·chapter-vii/section-1/article-79·chapter-vii/section-2/article-83/1·chapter-vii/section-2/article-87·chapter-vii/section-3/article-88/8·chapter-vii/section-3/article-95·chapter-vii/section-3/article-95/1·chapter-x/article-113/3;eu-machinery-regulationchapter-i/article-3·chapter-i/article-6/5·chapter-v/article-40/1;eu-mdrannex-i/chapter-i/3·annex-ix/chapter-i/2.1·annex-ix/chapter-i/3.2·annex-ix/chapter-i/3.3·annex-ix/chapter-ii·annex-vii/4.10·annex-vii/4.5.2·annex-vii/4.8·annex-xi/part-b·chapter-i/article-2·chapter-ii/article-10/10·chapter-ii/article-10/9·chapter-ii/article-15/3·chapter-ii/article-8/1·chapter-iii/article-33/2·chapter-vii/section-1/article-83·chapter-vii/section-1/article-83/1·chapter-vii/section-1/article-83/2·chapter-vii/section-1/article-83/3·chapter-vii/section-1/article-84·chapter-vii/section-2/article-88/1·chapter-vii/section-2/article-92·chapter-vii/section-3/article-100·chapter-vii/section-3/article-100/1·chapter-vii/section-3/article-93/8·chapter-x/article-123/3 - systemic risk 2 clauses:
eu-ai-actchapter-i/article-3·chapter-vii/section-1/article-68/3 - technical specifications 4 clauses:
eu-ai-actchapter-i/article-3·chapter-vii/section-1/article-66;eu-cyber-resilience-actannex-vii;eu-machinery-regulationchapter-i/article-3 - testing data 2 clauses:
eu-ai-actchapter-i/article-3·chapter-ix/section-3/article-74/12 - testing in real-world conditions 3 clauses:
eu-ai-actchapter-i/article-3·chapter-vi/article-60/4;eu-digital-omnibus-aiarticle-1/6 - training data 1 clause:
eu-ai-actchapter-i/article-3 - UDI 8 clauses:
eu-ivdrchapter-i/section-1/article-2·chapter-ii/article-10/8·chapter-iii/article-30/2·chapter-x/article-113/3;eu-mdrchapter-i/article-2·chapter-ii/article-10/9·chapter-iii/article-33/2·chapter-x/article-123/3 - Union harmonisation legislation 12 clauses:
eu-ai-actchapter-i/article-3·chapter-ix/section-3/article-74/10·chapter-ix/section-3/article-74/3·chapter-ix/section-3/article-79/2·chapter-vii/section-1/article-66;eu-cyber-resilience-actchapter-i/article-3·chapter-v/article-52/6;eu-digital-omnibus-aiarticle-1/6·article-1/9;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2 - Unique Device Identifier 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - user 12 clauses:
eu-ai-actchapter-viii/article-71/4;eu-cyber-resilience-actannex-vii·chapter-ii/article-13/16·chapter-ii/article-13/18·chapter-ii/article-13/8·chapter-ii/article-19/2·chapter-v/article-52/16;eu-ivdrannex-ix/chapter-ii·chapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrannex-ix/chapter-ii·chapter-i/article-2 - validation data 1 clause:
eu-ai-actchapter-i/article-3 - validation data set 1 clause:
eu-ai-actchapter-i/article-3 - vulnerability 9 clauses:
eu-cyber-resilience-actannex-vii·chapter-i/article-1·chapter-i/article-3·chapter-ii/article-13/8·chapter-ii/article-16/3·chapter-ii/article-19/5·chapter-ii/article-20/4·chapter-v/article-53·chapter-v/article-54/1 - webbing 1 clause:
eu-machinery-regulationchapter-i/article-3 - widespread infringement 1 clause:
eu-ai-actchapter-i/article-3 - withdrawal 18 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-4/article-36/6·chapter-iii/section-5/article-45/1·chapter-ix/section-3/article-79/9;eu-cyber-resilience-actchapter-i/article-3·chapter-iv/article-45/2·chapter-iv/article-49/1·chapter-v/article-54/9·chapter-v/article-57/1;eu-ivdrannex-vii/4.8·chapter-i/section-1/article-2·chapter-iv/article-42/6;eu-machinery-regulationchapter-i/article-3·chapter-v/article-36/2·chapter-v/article-40/1;eu-mdrannex-vii/4.8·chapter-i/article-2·chapter-iv/article-46/6 - withdrawal of an AI system 1 clause:
eu-ai-actchapter-i/article-3 - written 12 clauses:
eu-ai-actchapter-i/article-3·chapter-vi/article-57/7·chapter-vii/section-1/article-66;eu-cyber-resilience-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/6;eu-ivdrannex-ix/chapter-i/2.1·chapter-i/section-1/article-2·chapter-iv/article-42/6;eu-machinery-regulationchapter-i/article-3;eu-mdrannex-ix/chapter-i/2.1·annex-ix/chapter-ii·chapter-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 |
|---|---|---|---|---|
08b4462d76fa unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
acd195a087c3 (current) | 0 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
58dbc3006d27 | 0 | 115 | 14 | |
9d16077b1d3b (current) | 0 | 115 | 14 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
9206a43954eb (current) | 0 | 126 | 9 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
1fe6027daa2c (current) | 0 | 2 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
92eb86f25281 (current) | 0 | 21 | 3 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
903e40aaebe6 (current) | 1 | 63 | 8 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
1fc20ae2ffd8 | 0 | 35 | 5 | |
82fb682a6c54 (current) | 0 | 35 | 5 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
14d00b77d5c8 | 1 | 64 | 8 | |
fab624c8e1dc (current) | 1 | 64 | 8 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
2988351a1019 | 0 | 0 | 1 | |
f34e637e74cb (current) | 0 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
7337fc5e71ae | 0 | 0 | 1 | |
6e98d69dcbc7 | 0 | 0 | 1 | |
5ccba04e90a2 | 0 | 0 | 1 | |
aa1a23f2db97 | 0 | 0 | 1 | |
dd2f48968ac3 | 0 | 0 | 1 | |
6f27b489239b | 0 | 0 | 1 | |
d1d2dd4818e2 | 0 | 0 | 1 | |
a16f7063df22 | 0 | 0 | 1 | |
53985e50d069 | 0 | 0 | 1 | |
2cf39acc83b7 | 0 | 0 | 2 | |
0465b20f61c7 (current) | 0 | 0 | 2 |
Feed
/atom/term/market-surveillance.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 Cybersecurity Act | true | open | true | true |
| EU Machinery Regulation | true | open | true | true |
| 21 CFR Part 11 | true | open | true | true |
| EU Cyber Resilience Act | true | open | true | true |
| EU AI Act | true | open | true | true |
| EU GMP Annex 22 | true | open | true | true |
| EU GMP Annex 11 | true | open | true | true |
| 21 CFR Part 820 (QMSR) | true | open | true | true |
| EU NIS2 Directive | true | open | true | true |
| ICH Q9(R1) | true | open | true | true |
| Regulation (EU) 2026/1744 | 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: