Terms

332 terms, each one a tracked document defines in its own defining form, as the definitions derivation’s rules read them. 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. Each page gives the term where it sits, by structural position only: defined, in normative sentences, in titles, in body; with the clauses it shares with other terms, its history over each row’s texts and its own feed.

Which runs of printed words are listed under one key, and which rows are set beside one another under it, is this record’s fold (case set aside, spaces collapsed), never a statement that the documents mean one thing by it. 81 terms sit in rows of two or more jurisdictions; each of those pages opens with the line “shared term, no equivalence asserted”.

Counts are over each row’s current text: 81 of 126 current texts were read (81 read; 45 refused); a title is read for every one of the 132 tracked rows. Terms in code-unit order of their key. The derivation’s current version was first derived on 2026-10-31, read from state/terms-index.jsonl; its version, rules and term set are on the derivation methods page.

Rows printing each term, by position, over current texts and titles
Term as printed	Defined	In normative sentences	In titles	In body	Jurisdictions
accessory for a medical device	1	1	0	0	1
accessory for an in vitro diagnostic medical device	1	1	0	0	1
accreditation	2	6	0	6	1
Act	1	10	3	18	4
active device	1	1	0	1	1
Active device intended for diagnosis and monitoring	1	0	0	0	1
Active Process Controls	1	0	0	0	1
Active therapeutic device	1	0	0	0	1
actively exploited vulnerability	1	1	0	0	1
adverse event	2	6	0	4	3
Agency	1	20	0	34	5
agglomerate	1	1	0	0	1
aggregate	1	2	0	1	2
AI literacy	1	2	0	2	1
AI Office	1	2	0	2	1
AI regulatory sandbox	1	2	0	1	1
AI system	2	6	1	4	3
allow-list	1	1	0	0	1
analytical performance	1	1	0	1	1
Application	1	7	2	17	3
assurance level	1	3	0	3	1
Audits	1	2	0	1	2
authorised representative	5	6	0	5	1
Autonomous mobile machinery	1	1	0	0	1
Batch or lot	1	0	0	0	1
benefit-risk determination	2	2	0	0	1
biometric categorisation system	1	1	0	0	1
biometric data	1	1	0	1	1
biometric identification	1	1	0	2	1
biometric verification	1	1	0	1	1
Biometrics	1	1	0	2	2
Body orifice	1	0	0	0	1
calibrator	1	1	0	1	1
Carrier	1	0	0	0	1
CE marking	5	5	0	5	1
CE marking of conformity	2	2	0	2	1
Central circulatory system	1	0	0	0	1
Central nervous system	1	0	0	0	1
chains	1	5	0	8	3
clinical benefit	2	2	0	2	1
clinical data	1	5	0	3	2
clinical evaluation	1	2	0	1	1
clinical evidence	2	2	0	1	1
clinical investigation	1	3	0	2	2
clinical investigation plan	1	1	0	1	1
clinical performance	2	2	0	2	1
Closed system	1	0	0	2	2
Cloud Computing	1	0	0	0	1
cloud computing service	1	1	0	1	1
common specification	1	3	0	3	1
companion diagnostic	1	1	0	0	1
Component / component	2	18	0	17	4
Conformance to specification	1	1	0	0	1
conformity assessment	6	8	1	8	2
conformity assessment body	6	7	0	3	1
conformity self-assessment	1	1	0	0	1
consumer	1	4	0	6	2
content delivery network	1	1	0	0	1
control material	1	1	0	1	1
corrective action	2	8	0	6	3
critical infrastructure	1	2	0	4	2
CSIRT designated as coordinator	1	2	0	1	1
custom-made device	1	1	0	0	1
cyber threat	3	4	0	1	2
cybersecurity	3	12	0	14	3
cybersecurity risk	1	6	0	8	3
danger zone	1	1	0	0	1
data centre service	1	1	0	0	1
Decision Maker(s)	1	0	0	0	1
deep fake	1	1	0	0	1
deployer	1	2	0	2	1
derivative	1	1	0	1	1
Detectability	1	0	0	0	1
device deficiency	2	2	0	0	1
device for near-patient testing	1	1	0	0	1
device for performance study	1	1	0	1	1
device for self-testing	1	1	0	0	1
device software function	1	0	0	1	1
diagnostic sensitivity	1	1	0	0	1
diagnostic specificity	1	1	0	0	1
digital service	1	2	0	2	1
digital service provider	1	0	0	1	1
Digital signature	1	0	0	0	1
distinctive by design	1	0	0	1	1
distributor	5	6	0	2	1
Disturbances	1	1	0	1	1
Diversion	1	1	0	1	1
DNS	1	2	0	1	1
DNS service provider	1	1	0	0	1
domain name system	1	2	0	1	1
downstream provider	1	1	0	1	1
Driver	1	1	0	0	1
Durable Electronic Data Repository	1	0	0	0	1
Dynamic test	1	0	0	0	1
economic operator	4	5	0	4	1
electronic communications service	1	1	0	0	1
Electronic Data Capture (EDC) Systems	1	0	0	0	1
electronic information system	1	1	0	1	1
Electronic record	1	1	0	1	2
Electronic signature	1	1	0	1	1
Electronic Systems	1	0	1	1	1
emotion recognition system	1	1	0	0	1
end-point	1	1	0	1	1
end-to-end	1	2	0	1	2
entity	1	14	0	10	3
entity providing domain name registration services	1	1	0	0	1
essential health and safety requirements	1	5	0	3	1
ethics committee	2	3	0	3	1
European cybersecurity certificate	1	2	0	2	1
European cybersecurity certification scheme	1	3	0	3	1
European standard	1	4	0	0	1
exploitable vulnerability	1	1	0	0	1
exposed person	1	1	0	0	1
falsified device	2	2	0	0	1
Federal Food, Drug, and Cosmetic Act	1	2	0	9	1
field safety corrective action	2	2	0	1	1
field safety notice	2	2	0	0	1
Finished device	1	0	0	0	1
floating-point operation	1	1	0	0	1
free and open-source software	1	1	0	1	1
fully refurbishing	2	1	0	0	1
general-purpose AI model	1	1	0	1	1
general-purpose AI system	1	1	0	1	1
generic device group	2	2	0	0	1
guard	1	2	0	1	1
Guided load	1	0	0	0	1
Handwritten signature	1	0	0	0	1
hardware	1	16	0	12	3
Harm	1	0	0	2	2
harmonised standard	5	5	0	1	1
Hazard / hazard	2	11	0	2	2
Hazard Identification	1	0	0	1	1
health institution	2	2	0	0	1
high-impact capabilities	1	1	0	0	1
ICT process	2	2	0	1	1
ICT product	2	2	0	1	1
ICT service	2	2	0	2	1
identity management	1	1	0	0	1
implantable device	1	1	0	0	1
importer	5	9	0	5	2
in vitro diagnostic medical device	1	2	0	0	1
incident	5	13	0	10	4
incident handling	2	1	0	2	2
indirect connection	1	1	0	0	1
informed consent	3	5	0	5	2
Injured skin or mucous membrane	1	0	0	0	1
input data	1	3	0	4	3
instructions for use	4	6	0	4	2
intended purpose	4	11	0	10	3
intended use	1	22	0	17	3
interchangeable equipment	1	1	0	1	1
international standard	1	4	0	1	1
internet exchange point	1	1	0	0	1
interventional clinical performance study	1	1	0	0	1
invasive device	1	1	0	1	1
investigational device	1	2	0	1	2
investigator	2	6	0	4	2
IT Infrastructure	1	0	0	0	1
kit	1	1	0	2	2
label	2	11	0	8	4
large-scale cybersecurity incident	1	1	0	0	1
law enforcement	1	4	0	3	1
law enforcement authority	1	1	0	0	1
lay person	2	2	0	1	1
lifetime	1	6	0	4	2
lifting accessory	1	1	0	1	1
Lifting operation	1	0	0	0	1
likelihood ratio	1	1	0	0	1
logical connection	1	1	0	0	1
Long term	1	1	0	0	1
machinery	1	5	1	7	1
Machinery or related products for plant protection products application	1	1	0	1	1
Machinery or related products presenting risks due to their mobility	1	1	0	0	1
making available on the market	5	5	0	5	1
managed security service provider	1	1	0	0	1
managed service provider	1	1	0	0	1
manufacturer	4	37	0	26	3
market surveillance	2	7	0	10	4
market surveillance authority	3	4	0	3	1
Material Traceability	1	1	0	1	1
medical device	2	6	3	10	6
Metadata	1	3	0	5	2
micro, small and medium-sized enterprise	1	1	0	0	1
Model Maintenance	1	0	0	0	1
Multivariate Statistical Process Control	1	0	0	0	1
nanomaterial	1	1	0	1	1
national accreditation body	2	6	0	1	1
national competent authority	1	8	0	1	2
national cybersecurity certification scheme	1	0	0	0	1
national cybersecurity strategy	1	1	0	0	1
national strategy on the security of network and information systems	1	0	0	1	1
near miss	2	2	0	0	1
negative predictive value	1	1	0	0	1
network and information system	2	1	0	2	1
non-personal data	1	1	0	1	1
non-viable	1	2	0	1	1
notified body	5	7	0	5	1
notifying authority	2	4	0	1	1
online marketplace	1	2	0	1	1
online search engine	1	2	0	1	1
Open system	1	1	0	0	1
open-source software steward	1	1	0	0	1
operator	2	20	0	13	3
operator of essential services	1	0	0	1	1
particle	1	7	0	5	2
partly completed machinery	1	1	0	1	1
performance	1	34	0	31	3
performance evaluation	1	2	0	1	1
performance of a device	1	2	0	1	1
performance of an AI system	1	1	0	0	1
performance study	1	1	0	1	1
performance study plan	1	1	0	0	1
personal data	2	10	0	8	2
physical connection	1	1	0	0	1
placing on the market	5	6	0	6	1
positive predictive value	1	1	0	0	1
post-market monitoring system	1	2	0	0	1
post-market surveillance	2	2	0	4	3
post-remote biometric identification system	1	1	0	0	1
predictive value	1	1	0	0	1
procedure pack	1	1	0	0	1
Process Dynamics	1	0	0	1	1
Product Lifecycle	1	2	1	4	2
product with digital elements	1	2	0	1	1
professional user	1	2	0	0	1
profiling	1	1	0	1	1
protective device	1	1	0	0	1
provider	1	15	0	14	2
public administration entity	1	2	0	1	1
public electronic communications network	1	1	0	0	1
publicly accessible space	1	1	0	0	1
putting into service	4	5	0	5	1
qualified trust service	1	1	0	1	1
qualified trust service provider	1	1	0	0	1
Quality	1	36	9	42	3
Quality Risk Management	1	9	1	8	3
Quality System	1	8	2	16	3
real-time remote biometric identification system	1	1	0	0	1
real-world testing plan	1	2	0	1	1
reasonably foreseeable misuse	3	7	0	2	2
reasonably foreseeable use	1	1	0	1	1
recall	4	14	0	7	3
recall of an AI system	1	1	0	0	1
Remanufacturer	1	1	0	0	1
remote biometric identification system	1	1	0	0	1
remote data processing	1	1	0	1	1
removable mechanical transmission device	1	1	0	0	1
representative	1	28	0	17	3
reprocessing	1	6	0	2	3
Requirements	1	11	0	17	3
research organisation	1	1	0	0	1
Residence Time Distribution (RTD)	1	0	0	0	1
Reusable surgical instrument	1	0	0	0	1
Risk / risk	6	49	5	49	4
Risk Acceptance	1	0	0	1	1
Risk Analysis	1	0	0	1	1
Risk Assessment	1	3	0	9	3
Risk Communication	1	0	0	0	1
Risk Control	1	0	0	1	1
Risk Evaluation	1	0	0	1	1
Risk Management	1	14	2	13	3
Risk Reduction	1	0	0	1	1
Risk Review	1	0	0	1	1
Risk-Based Decision-Making	1	0	0	0	1
ropes	1	1	0	1	1
Run Time	1	1	0	1	1
safety component	3	3	0	2	1
safety function	1	3	0	1	1
sandbox plan	1	2	0	0	1
scientific validity of an analyte	1	0	0	0	1
security of network and information systems	1	2	0	2	1
sensitive operational data	1	1	0	0	1
serious adverse event	2	5	0	1	1
serious incident	3	3	0	0	1
serious public health threat	2	2	0	0	1
Severity	1	0	0	0	1
Short term	1	0	0	0	1
significant cyber threat	1	1	0	0	1
significant cybersecurity risk	1	2	0	1	2
single-use device	2	2	0	0	1
small mid-cap enterprise	1	1	0	0	1
SMC	1	1	0	0	1
SME	1	4	0	1	2
social networking services platform	1	1	0	0	1
Soft Sensors	1	0	0	0	1
software	1	21	6	26	6
software bill of materials	1	1	0	1	1
source code	1	4	0	2	2
special categories of personal data	1	3	0	1	1
specimen receptacle	1	1	0	0	1
sponsor	2	9	0	7	2
Stakeholder	1	1	0	3	3
standard	2	24	0	22	3
Static test	1	0	0	0	1
Steady State	1	0	0	0	1
subject	3	36	0	29	3
substantial modification	3	5	0	2	1
Supervisor	1	6	0	5	1
Supervisory function	1	1	0	0	1
support period	1	1	0	1	1
Surgically invasive device	1	0	0	0	1
System / system	2	50	8	57	4
systemic risk	1	2	0	2	1
technical specification	2	2	0	0	1
technical specifications	1	9	0	5	2
Test coefficient	1	0	0	0	1
testing data	1	3	0	1	1
testing in real-world conditions	1	2	0	1	1
Third Party	1	0	0	0	1
TLD name registry	1	1	0	0	1
top-level domain name registry	1	1	0	0	1
training data	1	4	0	5	3
Transient	1	1	0	1	2
Transient Events	1	0	0	0	1
Trend	1	0	0	3	2
trust service	1	2	0	1	1
trust service provider	1	1	0	0	1
UDI	2	4	0	2	2
Union harmonisation legislation	2	6	0	5	1
Unique Device Identifier	2	0	0	2	1
Unit Operation	1	0	0	1	1
user	2	22	0	17	3
User Acceptance Testing	1	0	0	0	1
validation data	1	7	0	2	3
validation data set	1	1	0	0	1
vulnerability	2	7	0	8	2
webbing	1	1	0	1	1
widespread infringement	1	1	0	0	1
withdrawal	4	11	0	1	2
withdrawal of an AI system	1	1	0	0	1
Working coefficient	1	0	0	0	1
written	1	42	0	15	3

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.

Rights envelope — how this record handles the text of each entry listed
Entry	`text_retained`	`licence_class`	`quote_allowed`	`snapshot_available`
EU MDR	`true`	`open`	`true`	`true`
EU IVDR	`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`
ICH Q13	`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`
FDA device cybersecurity	`true`	`open`	`true`	`true`
FDA device cybersecurity (2026)	`true`	`open`	`true`	`true`
EU GMP Annex 11	`true`	`open`	`true`	`true`
FDA electronic systems (clinical)	`true`	`open`	`true`	`true`
21 CFR Part 820 (QMSR)	`true`	`open`	`true`	`true`
EU NIS2 Directive	`true`	`open`	`true`	`true`
EU GMP Chapter 4 (draft)	`true`	`open`	`true`	`true`
ICH Q9(R1)	`true`	`open`	`true`	`true`
21 CFR Part 211	`true`	`open`	`true`	`true`
Regulation (EU) 2026/1744	`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 listed here. A row counted without its characters printed 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: 2 November 2026