MDCG guidance
MDCG 2022-19: Performance study application/notification documents under Regulation (EU) 2017/746
MDCG guidance · In Vitro Diagnostic medical devices (IVD) · December 2022
Key facts
| Reference | MDCG 2022-19 |
|---|---|
| Title | Performance study application/notification documents under Regulation (EU) 2017/746 |
| Topic | In Vitro Diagnostic medical devices (IVD) |
| Published | December 2022 |
| Document | health.ec.europa.eu |
At a glance
- Yes Full text searchable in Orca1
- MDCG 2022-19 (December 2022) Revisions on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MDCG guidance documents
The Medical Device Coordination Group (MDCG), made up of EU member-state experts, endorses guidance on applying the Medical Devices Regulation (EU) 2017/745 and the In Vitro Diagnostic Regulation (EU) 2017/746. Each page here covers one document and all of its revisions.