European Union Medical Device Regulation
GPTKB entity
Statements (42)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:legislation
|
| gptkbp:abbreviation |
gptkb:EU_MDR
|
| gptkbp:adoptedBy |
2017-04-05
|
| gptkbp:appliesTo |
gptkb:European_Economic_Area
manufacturers of medical devices authorized representatives of medical devices distributors of medical devices importers of medical devices |
| gptkbp:category |
medical device
European Union law health law |
| gptkbp:enforcedBy |
national competent authorities
|
| gptkbp:enteredIntoForce |
2017-05-25
|
| gptkbp:establishes |
EUDAMED database
|
| gptkbp:fullyApplicableFrom |
2021-05-26
|
| https://www.w3.org/2000/01/rdf-schema#label |
European Union Medical Device Regulation
|
| gptkbp:jurisdiction |
gptkb:European_Union
|
| gptkbp:language |
English
all official EU languages |
| gptkbp:number |
2017/745
|
| gptkbp:objective |
increase transparency
ensure safety and performance of medical devices improve traceability of medical devices strengthen market surveillance |
| gptkbp:officialName |
gptkb:Regulation_(EU)_2017/745
|
| gptkbp:publishedBy |
gptkb:Council_of_the_European_Union
gptkb:European_Parliament |
| gptkbp:publishedIn |
gptkb:Official_Journal_of_the_European_Union
|
| gptkbp:regulates |
medical devices
clinical investigations of medical devices post-market surveillance of medical devices |
| gptkbp:relatedTo |
In Vitro Diagnostic Medical Devices Regulation
|
| gptkbp:replacedBy |
Active Implantable Medical Device Directive
Medical Device Directive |
| gptkbp:requires |
clinical evaluation
vigilance reporting post-market clinical follow-up CE marking for medical devices unique device identification (UDI) |
| gptkbp:website |
https://health.ec.europa.eu/medical-devices-sector/new-regulations_en
|
| gptkbp:bfsParent |
gptkb:IEC_60601-1
|
| gptkbp:bfsLayer |
7
|