Statements (28)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
medical device
|
| gptkbp:adoptedBy |
2017-04-05
|
| gptkbp:appliesTo |
gptkb:European_Union
medical devices in vitro diagnostic devices (with IVDR) |
| gptkbp:category |
European Union law
medical device law |
| gptkbp:dateOfApplication |
2021-05-26
|
| gptkbp:enforcedBy |
gptkb:European_Parliament
|
| gptkbp:establishes |
EUDAMED database
|
| gptkbp:fullName |
gptkb:European_Union_Medical_Device_Regulation
|
| gptkbp:goal |
ensure safety and performance of medical devices
increase transparency and traceability |
| https://www.w3.org/2000/01/rdf-schema#label |
EU MDR
|
| gptkbp:language |
English
|
| gptkbp:regulates |
gptkb:Regulation_(EU)_2017/745
|
| gptkbp:relatedTo |
IVDR
|
| gptkbp:replacedBy |
Medical Device Directive (MDD)
Active Implantable Medical Device Directive (AIMDD) |
| gptkbp:requires |
gptkb:Unique_Device_Identification_(UDI)
clinical evaluation post-market surveillance vigilance reporting designation of a Person Responsible for Regulatory Compliance (PRRC) |
| gptkbp:scope |
regulates placing on the market and putting into service of medical devices in the EU
|
| gptkbp:website |
https://health.ec.europa.eu/medical-devices-sector/new-regulations_en
|
| gptkbp:bfsParent |
gptkb:Medical_Device_Regulation
|
| gptkbp:bfsLayer |
7
|