European Medical Device Regulation

GPTKB entity

Predicate	Object
gptkbp:instanceOf	gptkb:legislation
gptkbp:abbreviation	gptkb:MDR
gptkbp:adoptedBy	gptkb:European_Union 5 April 2017
gptkbp:appliesTo	medical devices in vitro diagnostic devices
gptkbp:category	gptkb:medical_device gptkb:European_Union_law
gptkbp:establishes	EUDAMED database
gptkbp:language	English all official EU languages
gptkbp:legalStatus	binding
gptkbp:officialName	gptkb:Regulation_(EU)_2017/745
gptkbp:publishedIn	gptkb:Official_Journal_of_the_European_Union
gptkbp:purpose	ensure safety and performance of medical devices harmonize medical device regulation across EU
gptkbp:referenceNumber	2017/745
gptkbp:regulates	manufacturers of medical devices distributors of medical devices importers of medical devices
gptkbp:relatedTo	In Vitro Diagnostic Regulation
gptkbp:replacedBy	Active Implantable Medical Device Directive Medical Device Directive
gptkbp:requires	gptkb:CE_marking clinical evaluation post-market surveillance unique device identification
gptkbp:scope	gptkb:European_Economic_Area
gptkbp:startDate	26 May 2021
gptkbp:bfsParent	gptkb:EN_60601
gptkbp:bfsLayer	7
https://www.w3.org/2000/01/rdf-schema#label	European Medical Device Regulation