MDCG guidance
MDCG 2021-13 Rev. 1: Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR
MDCG guidance · EUDAMED · July 2021
Key facts
| Reference | MDCG 2021-13 Rev. 1 |
|---|---|
| Title | Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR |
| Topic | EUDAMED |
| Published | July 2021 |
| Document | health.ec.europa.eu |
At a glance
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- MDCG 2021-13 Rev. 1 (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.