In Vitro Diagnostic Regulation (IVDR)
GPTKB entity
Statements (29)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
European Union law
|
| gptkbp:abbreviation |
IVDR
|
| gptkbp:adoptedBy |
gptkb:European_Union
5 April 2017 |
| gptkbp:aimsTo |
increase transparency
strengthen market surveillance ensure safety and performance of in vitro diagnostic devices |
| gptkbp:applicableFrom |
26 May 2022
|
| gptkbp:appliesTo |
gptkb:European_Economic_Area
|
| gptkbp:enteredIntoForce |
26 May 2017
|
| gptkbp:establishes |
EUDAMED database requirements
post-market surveillance requirements requirements for notified bodies stricter classification rules vigilance reporting requirements |
| gptkbp:fullName |
Regulation (EU) 2017/746 on in vitro diagnostic medical devices
|
| https://www.w3.org/2000/01/rdf-schema#label |
In Vitro Diagnostic Regulation (IVDR)
|
| gptkbp:language |
English
all official EU languages |
| gptkbp:legalCitation |
Regulation (EU) 2017/746
|
| gptkbp:publishedIn |
gptkb:Official_Journal_of_the_European_Union
|
| gptkbp:regulates |
in vitro diagnostic medical devices
|
| gptkbp:relatedTo |
Medical Device Regulation (MDR)
|
| gptkbp:replacedBy |
In Vitro Diagnostic Medical Devices Directive (IVDD)
|
| gptkbp:requires |
CE marking for in vitro diagnostic devices
clinical evidence for device performance |
| gptkbp:bfsParent |
gptkb:Medical_Device_Regulation
gptkb:EN_ISO_14971 |
| gptkbp:bfsLayer |
7
|