MDR

E458512

European Union regulation medical device regulation

MDR is the European Union’s comprehensive regulatory framework governing the safety, performance, and market approval of medical devices.

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Statements (48)

Predicate	Object
instanceOf	European Union regulation ⓘ medical device regulation ⓘ
adoptionDate	2017-04-05 ⓘ
alsoKnownAs	Medical Device Regulation NERFINISHED ⓘ
appliesTo	authorised representatives of manufacturers ⓘ distributors of medical devices ⓘ importers of medical devices ⓘ manufacturers of medical devices ⓘ
classificationSystem	risk-based classification into classes I, IIa, IIb, III ⓘ
contains	Annex I General Safety and Performance Requirements ⓘ Annex IX Conformity Assessment based on a Quality Management System and on Assessment of Technical Documentation ⓘ Annex VIII Classification Rules NERFINISHED ⓘ Annex X Clinical Evaluation ⓘ Annex XIV Clinical Evaluation and Post-market Clinical Follow-up ⓘ
effectiveDate	2017-05-25 ⓘ
establishes	European database on medical devices (EUDAMED) NERFINISHED ⓘ
fullApplicationDate	2021-05-26 ⓘ
fullName	Regulation (EU) 2017/745 NERFINISHED ⓘ
governs	market approval of medical devices in the EU ⓘ performance of medical devices in the EU market ⓘ safety of medical devices in the EU market ⓘ
introduces	increased transparency through EUDAMED database ⓘ more stringent rules for notified bodies ⓘ person responsible for regulatory compliance ⓘ stricter requirements for clinical evidence ⓘ unique device identification system ⓘ
jurisdiction	European Union ⓘ
legalBasis	Article 114 of the Treaty on the Functioning of the European Union NERFINISHED ⓘ
objective	ensure high level of protection of health for patients and users ⓘ ensure smooth functioning of the internal market for medical devices ⓘ
publicationDate	2017-05-05 ⓘ
regulates	clinical evaluation of medical devices ⓘ conformity assessment of medical devices ⓘ market surveillance of medical devices ⓘ post-market surveillance of medical devices ⓘ registration of devices and economic operators ⓘ vigilance and incident reporting for medical devices ⓘ
replaces	Active Implantable Medical Devices Directive 90/385/EEC NERFINISHED ⓘ Medical Devices Directive 93/42/EEC NERFINISHED ⓘ
requires	CE marking for medical devices ⓘ implant cards for patients with implantable devices ⓘ periodic safety update reports for certain devices ⓘ post-market clinical follow-up where appropriate ⓘ quality management system for manufacturers ⓘ risk management system for medical devices ⓘ
scope	accessories for medical devices ⓘ certain groups of products without an intended medical purpose ⓘ medical devices ⓘ

Referenced by (1)

Full triples — surface form annotated when it differs from this entity's canonical label.

European Union medical device regulations → hasAbbreviation → MDR ⓘ