EU In Vitro Diagnostic Regulation (IVDR)
GPTKB entity
Statements (26)
| Predicate | Object |
|---|---|
| gptkbp:instance_of |
gptkb:municipality
|
| gptkbp:bfsLayer |
8
|
| gptkbp:bfsParent |
gptkb:European_Database_on_Medical_Devices_(EUDAMED)
|
| gptkbp:addresses |
IVD software regulations
|
| gptkbp:aims_to |
ensure safety and performance of IV Ds
|
| gptkbp:applies_to |
in vitro diagnostic medical devices
companion diagnostics laboratory developed tests (LD Ts) |
| gptkbp:effective_date |
May 26, 2022
|
| gptkbp:enacted_by |
gptkb:legislation
|
| gptkbp:enhances |
transparency in the IVD market
|
| gptkbp:established |
gptkb:European_Database_on_Medical_Devices_(EUDAMED)
|
| gptkbp:facilitates |
market access for innovative IV Ds
|
| https://www.w3.org/2000/01/rdf-schema#label |
EU In Vitro Diagnostic Regulation (IVDR)
|
| gptkbp:includes |
requirements for notified bodies
|
| gptkbp:influence |
stricter requirements for manufacturers
|
| gptkbp:introduced |
new classification rules
|
| gptkbp:is_monitored_by |
gptkb:European_Medicines_Agency_(EMA)
|
| gptkbp:is_part_of |
EU Medical Device Regulation framework
|
| gptkbp:is_related_to |
healthcare regulations
|
| gptkbp:is_supported_by |
guidance documents
|
| gptkbp:mandates |
post-market surveillance
|
| gptkbp:promotes |
patient safety
|
| gptkbp:replaced_by |
IVDD
|
| gptkbp:requires |
labeling and instructions for use
clinical evidence for IV Ds |