European Union medical device regulations
E100892
European Union medical device regulations are a comprehensive set of legal and technical requirements governing the safety, performance, quality management, and market approval of medical devices within EU member states.
All labels observed (5)
| Label | Occurrences |
|---|---|
| EU In Vitro Diagnostic Regulation | 1 |
| EU MDR | 1 |
| EU Medical Device Regulation | 1 |
| European Union medical device regulations canonical | 1 |
| Regulation (EU) 2017/745 on medical devices | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T868450 — resolving that mention is where its identity was fixed. The disambiguator weighed these candidate entities and picked the highlighted one (or “None”, minting a new entity). This is how homonymy is resolved: the same surface form can point to different entities.
NED1
Entity disambiguation (via context triple)
gpt-5-mini-2025-08-07
Target entity: European Union medical device regulations Context triple: [ISO 13485, relatedTo, European Union medical device regulations]
-
A.
European Medicines Agency
The European Medicines Agency is the European Union’s regulatory authority responsible for the scientific evaluation, supervision, and safety monitoring of medicines for human and veterinary use.
-
B.
IEEE 11073 medical device communication standards
IEEE 11073 medical device communication standards are a family of international standards that define interoperable data exchange and integration between medical devices and healthcare information systems.
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C.
Center for Devices and Radiological Health
The Center for Devices and Radiological Health is the U.S. FDA division responsible for regulating medical devices and radiation-emitting products to ensure their safety and effectiveness.
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D.
Regulation (EU) 1292/2013
Regulation (EU) 1292/2013 is an EU legislative act that sets out the framework, objectives, and operational rules for the European Institute of Innovation and Technology and its activities.
-
E.
European Directorate for the Quality of Medicines & HealthCare
The European Directorate for the Quality of Medicines & HealthCare is a Council of Europe body responsible for developing quality standards and guidance to ensure the safety and efficacy of medicines and improve healthcare across member states.
- F. None of above. chosen
- G. Unsure - the case is ambiguous/there is not enough information to decide.
NED2
Entity disambiguation (via description)
gpt-5-mini-2025-08-07
Target entity: European Union medical device regulations Target entity description: European Union medical device regulations are a comprehensive set of legal and technical requirements governing the safety, performance, quality management, and market approval of medical devices within EU member states.
-
A.
European Medicines Agency
The European Medicines Agency is the European Union’s regulatory authority responsible for the scientific evaluation, supervision, and safety monitoring of medicines for human and veterinary use.
-
B.
IEEE 11073 medical device communication standards
IEEE 11073 medical device communication standards are a family of international standards that define interoperable data exchange and integration between medical devices and healthcare information systems.
-
C.
Center for Devices and Radiological Health
The Center for Devices and Radiological Health is the U.S. FDA division responsible for regulating medical devices and radiation-emitting products to ensure their safety and effectiveness.
-
D.
Regulation (EU) 1292/2013
Regulation (EU) 1292/2013 is an EU legislative act that sets out the framework, objectives, and operational rules for the European Institute of Innovation and Technology and its activities.
-
E.
European Directorate for the Quality of Medicines & HealthCare
The European Directorate for the Quality of Medicines & HealthCare is a Council of Europe body responsible for developing quality standards and guidance to ensure the safety and efficacy of medicines and improve healthcare across member states.
- F. None of above. chosen
Statements (49)
| Predicate | Object |
|---|---|
| instanceOf |
medical device regulation system
ⓘ
regulatory framework ⓘ |
| aimsTo |
ensure high level of protection of health for patients and users
ⓘ
ensure smooth functioning of the internal market for medical devices ⓘ |
| appliesInJurisdiction |
European Economic Area
ⓘ
European Union ⓘ |
| defines |
classification rules for in vitro diagnostic medical devices
ⓘ
classification rules for medical devices ⓘ |
| enteredIntoForce | 2017 ⓘ |
| governs |
accessory to a medical device
ⓘ
in vitro diagnostic medical devices ⓘ medical devices ⓘ |
| hasAbbreviation |
European Union medical device regulations
self-linksurface differs
ⓘ
surface form:
EU MDR
IVDR ⓘ MDR ⓘ |
| hasCoreInstrument |
European Union medical device regulations
self-linksurface differs
ⓘ
surface form:
Regulation (EU) 2017/745 on medical devices
Regulation (EU) 2017/746 on in vitro diagnostic medical devices ⓘ |
| imposesObligationOn |
authorised representatives
ⓘ
distributors ⓘ importers ⓘ medical device manufacturers ⓘ |
| includesConcept |
general safety and performance requirements
ⓘ
market surveillance by competent authorities ⓘ post-market clinical follow-up ⓘ vigilance system for serious incidents ⓘ |
| isBasedOnLegalAuthority | Treaty on the Functioning of the European Union ⓘ |
| IVDRDateOfApplication | 26 May 2022 ⓘ |
| MDRDateOfApplication | 26 May 2021 ⓘ |
| providesFor | transitional provisions from directives to regulations ⓘ |
| replaced |
Council Directive 90/385/EEC on active implantable medical devices
ⓘ
Council Directive 93/42/EEC on medical devices ⓘ Directive 98/79/EC on in vitro diagnostic medical devices ⓘ |
| requires |
CE marking for medical devices
ⓘ
appointment of a notified body for higher-risk devices ⓘ designation of a person responsible for regulatory compliance ⓘ registration of devices in EUDAMED ⓘ registration of economic operators in EUDAMED ⓘ |
| requiresComplianceWith | harmonised standards for medical devices ⓘ |
| setsRequirement |
clinical evaluation
ⓘ
clinical investigation ⓘ clinical performance of medical devices ⓘ conformity assessment ⓘ post-market surveillance ⓘ quality management systems for manufacturers ⓘ risk management ⓘ safety of medical devices ⓘ technical documentation ⓘ unique device identification ⓘ vigilance reporting ⓘ |
How these facts were elicited
The pipeline generated the facts above by prompting gpt-5.1 with this entity's name + description and the instruction below.
Instruction
You are a knowledge base construction expert. Given a subject entity and a description of it, return factual statements that you know for the subject as a JSON list of dictionaries(triples), where keys must be "subject", "predicate" and "object". The number of facts may be very high, between 25 to 50 or more, for very popular subjects. For less popular subjects, the number of facts can be very low, like 5 or 10. # Requirements - If you don't know the subject at all, return an empty list. - If the subject is not a named entity, return an empty list. - Include at least one triple where predicate is "instanceOf". - Do not get too wordy. - Separate several objects into multiple triples with one object.
Input
Subject: European Union medical device regulations Description of subject: European Union medical device regulations are a comprehensive set of legal and technical requirements governing the safety, performance, quality management, and market approval of medical devices within EU member states.
Referenced by (5)
Full triples — surface form annotated when it differs from this entity's canonical label.
this entity surface form:
EU Medical Device Regulation
this entity surface form:
EU In Vitro Diagnostic Regulation
European Union medical device regulations
→
hasCoreInstrument
→
European Union medical device regulations
self-linksurface differs
ⓘ
this entity surface form:
Regulation (EU) 2017/745 on medical devices
European Union medical device regulations
→
hasAbbreviation
→
European Union medical device regulations
self-linksurface differs
ⓘ
this entity surface form:
EU MDR