European Medical Device Regulation
GPTKB entity
Statements (32)
| 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 |
medical device
European Union law |
| gptkbp:establishes |
EUDAMED database
|
| https://www.w3.org/2000/01/rdf-schema#label |
European Medical Device Regulation
|
| 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
|