MDCG guidance
MDCG 2021-22 rev.1: Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746
MDCG guidance · In Vitro Diagnostic medical devices (IVD) · September 2022
Key facts
| Reference | MDCG 2021-22 rev.1 |
|---|---|
| Title | Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746 |
| Topic | In Vitro Diagnostic medical devices (IVD) |
| Published | September 2022 |
| Document | health.ec.europa.eu |
At a glance
- Yes Full text searchable in Orca1
- MDCG 2021-22 rev.1 (September 2022), MDCG 2021-22 (August 2021) Revisions on file
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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.