Statements (52)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
medical device
|
| gptkbp:abbreviation |
gptkb:EU_MDR
|
| gptkbp:adoptedBy |
gptkb:European_Union
5 April 2017 |
| gptkbp:appliesTo |
gptkb:European_Economic_Area
medical devices in vitro diagnostic medical devices |
| gptkbp:category |
gptkb:legislation
|
| gptkbp:enforcedBy |
gptkb:European_Parliament
national competent authorities |
| gptkbp:establishes |
EUDAMED database
|
| gptkbp:fullName |
gptkb:European_Union_Medical_Device_Regulation
|
| gptkbp:goal |
ensure safety and performance of medical devices
harmonize medical device regulation across EU |
| https://www.w3.org/2000/01/rdf-schema#label |
European Union MDR
|
| gptkbp:language |
English
all official EU languages |
| gptkbp:publishedIn |
gptkb:Official_Journal_of_the_European_Union
|
| gptkbp:regulates |
gptkb:Regulation_(EU)_2017/745
|
| gptkbp:relatedTo |
European Union IVDR
|
| gptkbp:replacedBy |
Medical Device Directive (MDD)
Active Implantable Medical Device Directive (AIMDD) |
| gptkbp:requires |
clinical evaluation
increased transparency post-market surveillance CE marking for medical devices unique device identification (UDI) |
| gptkbp:startDate |
26 May 2021
|
| gptkbp:subject |
public health
labeling requirements risk management clinical data market surveillance implantable devices conformity assessment medical device safety device registration device classification transitional provisions vigilance reporting clinical investigation custom-made devices device traceability distributor obligations importer obligations legacy devices manufacturer obligations notified bodies reprocessing of single-use devices software as a medical device |
| gptkbp:bfsParent |
gptkb:IEC_60601-1-2
|
| gptkbp:bfsLayer |
7
|