European Union medical device regulations

E100892

medical device regulation system regulatory framework

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.

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All labels observed (6)

Label	Occurrences
EU In Vitro Diagnostic Regulation	1
EU MDR	1
EU Medical Device Regulation	1
European Union medical device regulations canonical	1
Medical Device Regulation	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.
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
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	EU MDR ⓘ linked to: European Union medical device regulations IVDR ⓘ MDR ⓘ
hasCoreInstrument	Regulation (EU) 2017/745 on medical devices ⓘ linked to: European Union medical device regulations 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