MDCG guidance
MDCG 2021-16 rev.1: Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices regulation ( IVDR) Annex to Application Form & PAR Template IVDR (List of documents)
MDCG guidance · Notified bodies · January 2025
Key facts
| Reference | MDCG 2021-16 rev.1 |
|---|---|
| Title | Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices regulation ( IVDR ) Annex to Application Form & PAR Template IVDR (List of documents) |
| Topic | Notified bodies |
| Published | January 2025 |
| Document | health.ec.europa.eu |
At a glance
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- MDCG 2021-16 rev.1 (January 2025), MDCG 2021-16 (July 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.