harmonised standard
This form is printed by the
tracked documents, each as a document defines it. The index’s key is
harmonised standard (the definitions derivation’s fold:
case set aside, spaces collapsed; each form is matched exactly as printed).
8 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
5 definitions in 5 current texts, as the definitions derivation’s rules read them, quoted where the term and its text together sit under the quote cap.
- EU AI Act
EUtext first observedchapter-i/article-3(27)harmonised standard: text withheld (over the cap: its term and text are 18 words)
- EU Cyber Resilience Act
EUtext first observedchapter-i/article-3(36)harmonised standard: text withheld (over the cap: its term and text are 18 words)
- EU IVDR
EUtext first observedchapter-i/section-1/article-2(73)harmonised standard: text withheld (end not delimited: no definition is read after it in this text)
- EU Machinery Regulation
EUtext first observedchapter-i/article-3(24)harmonised standard: text withheld (over the cap: its term and text are 20 words)
- EU MDR
EUtext first observedchapter-i/article-2(70)harmonised standard: text withheld (end not delimited: a heading the clause anchors read lies between it and the next definition read)
In normative sentences
33 sentences in 5 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
EU12 sentences; text first observedno clause anchor before this sentence: 3 sentences (should) ·chapter-i/article-3: 1 sentence (may, shall) ·chapter-iii/section-5/article-41/1: 1 sentence (may, is expected) ·chapter-iii/section-5/article-41/4: 2 sentences (shall) ·chapter-iii/section-5/article-43/1: 1 sentence (shall) ·chapter-v/section-2/article-53/4: 2 sentences (may, shall) ·chapter-v/section-3/article-55/2: 2 sentences (may, shall) - EU Cyber Resilience Act
EU6 sentences; text first observedno clause anchor before this sentence: 1 sentence (should) ·chapter-i/article-3: 1 sentence (may) ·chapter-iii/article-27/2: 1 sentence (shall, is expected) ·chapter-iii/article-27/6: 2 sentences (shall) ·annex-viii/part-iv/3.3: 1 sentence (shall) - EU IVDR
EU3 sentences; text first observedchapter-i/section-1/article-2: 1 sentence (shall, may) ·annex-ii/4: 1 sentence (shall) ·annex-ix/chapter-i/2.3: 1 sentence (shall) - EU Machinery Regulation
EU9 sentences; text first observedno clause anchor before this sentence: 2 sentences (should) ·chapter-i/article-3: 1 sentence (may) ·chapter-iii/article-20/3: 1 sentence (shall, is expected) ·chapter-iii/article-20/7: 2 sentences (shall) ·annex-iii/part-b/5: 1 sentence (shall) ·annex-ix/3.3: 1 sentence (shall) ·annex-x/4: 1 sentence (shall) - EU MDR
EU3 sentences; text first observedchapter-i/article-2: 1 sentence (shall, may) ·annex-ii/4: 1 sentence (shall) ·annex-ix/chapter-i/2.3: 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
1 occurrence in 1 current text 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.
- EU Cyber Resilience Act
EU1 occurrence; text first observed1 where no heading is read before it
Co-occurrence
212 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. 7 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 1 clause:
eu-machinery-regulationchapter-i/article-3 - active device 1 clause:
eu-mdrchapter-i/article-2 - actively exploited vulnerability 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - 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 - AI literacy 1 clause:
eu-ai-actchapter-i/article-3 - AI Office 1 clause:
eu-ai-actchapter-i/article-3 - AI regulatory sandbox 1 clause:
eu-ai-actchapter-i/article-3 - AI system 2 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-5/article-43/1 - analytical performance 1 clause:
eu-ivdrchapter-i/section-1/article-2 - Application 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - authorised representative 8 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actannex-viii/part-iv/3.3·chapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·annex-ix/3.3·chapter-i/article-3;eu-mdrchapter-i/article-2 - Autonomous mobile machinery 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - benefit-risk determination 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - biometric categorisation system 1 clause:
eu-ai-actchapter-i/article-3 - biometric data 1 clause:
eu-ai-actchapter-i/article-3 - biometric identification 1 clause:
eu-ai-actchapter-i/article-3 - biometric verification 1 clause:
eu-ai-actchapter-i/article-3 - calibrator 1 clause:
eu-ivdrchapter-i/section-1/article-2 - Carrier 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - CE marking 5 clauses:
eu-ai-actchapter-i/article-3;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 - CE marking of conformity 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - chains 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - 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 1 clause:
eu-mdrchapter-i/article-2 - clinical evidence 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - clinical investigation 1 clause:
eu-mdrchapter-i/article-2 - clinical investigation plan 1 clause:
eu-mdrchapter-i/article-2 - clinical performance 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - common specification 2 clauses:
eu-ai-actchapter-i/article-3;eu-machinery-regulationannex-x/4 - companion diagnostic 1 clause:
eu-ivdrchapter-i/section-1/article-2 - Component / component 4 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - conformity assessment 7 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-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrchapter-i/article-2 - conformity assessment body 5 clauses:
eu-ai-actchapter-i/article-3;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 - consumer 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - 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 - critical infrastructure 1 clause:
eu-ai-actchapter-i/article-3 - CSIRT designated as coordinator 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - custom-made device 1 clause:
eu-mdrchapter-i/article-2 - cyber threat 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - cybersecurity 3 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-iii/article-27/2·chapter-iii/article-27/6 - cybersecurity risk 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - danger zone 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - deep fake 1 clause:
eu-ai-actchapter-i/article-3 - deployer 1 clause:
eu-ai-actchapter-i/article-3 - derivative 1 clause:
eu-mdrchapter-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 5 clauses:
eu-ai-actchapter-i/article-3;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 - downstream provider 1 clause:
eu-ai-actchapter-i/article-3 - Driver 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - Dynamic test 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - economic operator 4 clauses:
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 - electronic information system 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - 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 6 clauses:
eu-machinery-regulationannex-iii/part-b/5·annex-ix/3.3·annex-x/4·chapter-i/article-3·chapter-iii/article-20/3·chapter-iii/article-20/7 - ethics committee 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - 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 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 - floating-point operation 1 clause:
eu-ai-actchapter-i/article-3 - free and open-source software 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - fully refurbishing 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - general-purpose AI model 1 clause:
eu-ai-actchapter-i/article-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 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - Guided load 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - hardware 2 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-machinery-regulationannex-iii/part-b/5 - Hazard / hazard 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-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 5 clauses:
eu-ai-actchapter-i/article-3;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 - in vitro diagnostic medical device 1 clause:
eu-ivdrchapter-i/section-1/article-2 - incident 4 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - indirect connection 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - informed consent 3 clauses:
eu-ai-actchapter-i/article-3;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 6 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrchapter-i/article-2 - intended purpose 9 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrannex-ii/4·annex-ix/chapter-i/2.3·chapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrannex-ii/4·annex-ix/chapter-i/2.3·chapter-i/article-2 - intended use 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - interchangeable equipment 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-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 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - law enforcement 2 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-5/article-43/1 - 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 4 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrchapter-i/article-2 - lifting accessory 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - Lifting operation 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - likelihood ratio 1 clause:
eu-ivdrchapter-i/section-1/article-2 - logical connection 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - machinery 4 clauses:
eu-machinery-regulationannex-iii/part-b/5·annex-ix/3.3·annex-x/4·chapter-i/article-3 - Machinery or related products for plant protection products application 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - Machinery or related products presenting risks due to their mobility 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - making available on the market 5 clauses:
eu-ai-actchapter-i/article-3;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 - manufacturer 11 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actannex-viii/part-iv/3.3·chapter-i/article-3;eu-ivdrannex-ix/chapter-i/2.3·chapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·annex-ix/3.3·annex-x/4·chapter-i/article-3;eu-mdrannex-ix/chapter-i/2.3·chapter-i/article-2 - market surveillance 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 - market surveillance authority 4 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-5/article-43/1;eu-cyber-resilience-actchapter-i/article-3;eu-machinery-regulationchapter-i/article-3 - medical device 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - nanomaterial 1 clause:
eu-mdrchapter-i/article-2 - national accreditation body 1 clause:
eu-machinery-regulationchapter-i/article-3 - national competent authority 1 clause:
eu-ai-actchapter-i/article-3 - 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 1 clause:
eu-mdrchapter-i/article-2 - notified body 11 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-5/article-43/1;eu-cyber-resilience-actannex-viii/part-iv/3.3·chapter-i/article-3;eu-ivdrannex-ix/chapter-i/2.3·chapter-i/section-1/article-2;eu-machinery-regulationannex-ix/3.3·annex-x/4·chapter-i/article-3;eu-mdrannex-ix/chapter-i/2.3·chapter-i/article-2 - notifying authority 2 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3 - open-source software steward 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - operator 6 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrchapter-i/article-2 - particle 1 clause:
eu-mdrchapter-i/article-2 - partly completed machinery 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - performance 6 clauses:
eu-ai-actchapter-i/article-3;eu-ivdrannex-ii/4·chapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-ii/4·chapter-i/article-2 - performance evaluation 1 clause:
eu-ivdrchapter-i/section-1/article-2 - 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 1 clause:
eu-ivdrchapter-i/section-1/article-2 - performance study plan 1 clause:
eu-ivdrchapter-i/section-1/article-2 - personal data 2 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3 - physical connection 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - placing on the market 6 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrchapter-i/article-2 - positive predictive value 1 clause:
eu-ivdrchapter-i/section-1/article-2 - post-market monitoring system 1 clause:
eu-ai-actchapter-i/article-3 - post-market surveillance 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - post-remote biometric identification system 1 clause:
eu-ai-actchapter-i/article-3 - predictive value 1 clause:
eu-ivdrchapter-i/section-1/article-2 - procedure pack 1 clause:
eu-mdrchapter-i/article-2 - product with digital elements 2 clauses:
eu-cyber-resilience-actannex-viii/part-iv/3.3·chapter-i/article-3 - professional user 2 clauses:
eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2 - profiling 1 clause:
eu-ai-actchapter-i/article-3 - protective device 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - provider 2 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-5/article-43/1 - publicly accessible space 1 clause:
eu-ai-actchapter-i/article-3 - putting into service 5 clauses:
eu-ai-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrchapter-i/article-2 - real-time remote biometric identification system 1 clause:
eu-ai-actchapter-i/article-3 - real-world testing plan 1 clause:
eu-ai-actchapter-i/article-3 - reasonably foreseeable misuse 3 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-machinery-regulationannex-iii/part-b/5 - reasonably foreseeable use 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - recall 5 clauses:
eu-ai-actchapter-i/article-3;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 - recall of an AI system 1 clause:
eu-ai-actchapter-i/article-3 - remote biometric identification system 1 clause:
eu-ai-actchapter-i/article-3 - remote data processing 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - removable mechanical transmission device 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - representative 10 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actannex-viii/part-iv/3.3·chapter-i/article-3;eu-ivdrannex-ix/chapter-i/2.3·chapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·annex-ix/3.3·chapter-i/article-3;eu-mdrannex-ix/chapter-i/2.3·chapter-i/article-2 - reprocessing 1 clause:
eu-mdrchapter-i/article-2 - Requirements 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - Risk / risk 8 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-5/article-43/1·chapter-v/section-3/article-55/2;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrchapter-i/article-2 - ropes 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - safety component 2 clauses:
eu-ai-actchapter-i/article-3;eu-machinery-regulationchapter-i/article-3 - safety function 3 clauses:
eu-ai-actchapter-i/article-3;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - sandbox plan 1 clause:
eu-ai-actchapter-i/article-3 - scientific validity of an analyte 1 clause:
eu-ivdrchapter-i/section-1/article-2 - sensitive operational data 1 clause:
eu-ai-actchapter-i/article-3 - serious adverse event 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - serious incident 3 clauses:
eu-ai-actchapter-i/article-3;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 - significant cybersecurity risk 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - single-use device 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - software 5 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrchapter-i/article-2 - software bill of materials 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - source code 2 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-machinery-regulationchapter-i/article-3 - 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 22 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-5/article-41/1·chapter-iii/section-5/article-41/4·chapter-iii/section-5/article-43/1·chapter-v/section-2/article-53/4·chapter-v/section-3/article-55/2;eu-cyber-resilience-actannex-viii/part-iv/3.3·chapter-i/article-3·chapter-iii/article-27/2·chapter-iii/article-27/6;eu-ivdrannex-ii/4·annex-ix/chapter-i/2.3·chapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·annex-ix/3.3·annex-x/4·chapter-i/article-3·chapter-iii/article-20/3·chapter-iii/article-20/7;eu-mdrannex-ii/4·annex-ix/chapter-i/2.3·chapter-i/article-2 - Static test 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - subject 5 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5;eu-mdrchapter-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 2 clauses:
eu-ai-actchapter-i/article-3;eu-machinery-regulationannex-iii/part-b/5 - Supervisory function 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - support period 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - System / system 11 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-5/article-43/1;eu-cyber-resilience-actannex-viii/part-iv/3.3·chapter-i/article-3;eu-ivdrannex-ix/chapter-i/2.3·chapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·annex-ix/3.3·chapter-i/article-3;eu-mdrannex-ix/chapter-i/2.3·chapter-i/article-2 - systemic risk 2 clauses:
eu-ai-actchapter-i/article-3·chapter-v/section-3/article-55/2 - technical specification 1 clause:
eu-cyber-resilience-actannex-viii/part-iv/3.3 - technical specifications 2 clauses:
eu-ai-actchapter-i/article-3;eu-machinery-regulationchapter-i/article-3 - Test coefficient 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - testing data 1 clause:
eu-ai-actchapter-i/article-3 - testing in real-world conditions 1 clause:
eu-ai-actchapter-i/article-3 - training data 1 clause:
eu-ai-actchapter-i/article-3 - UDI 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - Union harmonisation legislation 6 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-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 4 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrchapter-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 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - webbing 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - widespread infringement 1 clause:
eu-ai-actchapter-i/article-3 - withdrawal 5 clauses:
eu-ai-actchapter-i/article-3;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 - withdrawal of an AI system 1 clause:
eu-ai-actchapter-i/article-3 - Working coefficient 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - written 6 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;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 |
|---|---|---|---|---|
58dbc3006d27 | 1 | 12 | 0 | |
9d16077b1d3b (current) | 1 | 12 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
9206a43954eb (current) | 1 | 6 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
903e40aaebe6 (current) | 1 | 3 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
1fc20ae2ffd8 | 1 | 9 | 0 | |
82fb682a6c54 (current) | 1 | 9 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
14d00b77d5c8 | 1 | 3 | 0 | |
fab624c8e1dc (current) | 1 | 3 | 0 |
Feed
/atom/term/harmonised-standard.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 AI Act | true | open | true | true |
| EU Cyber Resilience Act | true | open | true | true |
| EU IVDR | true | open | true | true |
| EU Machinery Regulation | true | open | true | true |
| EU MDR | true | open | true | true |
| EU Cybersecurity 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: