Update MDCG-Dokumente und neue Benannte Stellen
Hier finden Sie alle Links zu den neuen MDCG-Dokumenten:
- 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 2021-14: Explanatory note on IVDR codes
- MDCG 2021-15 to 18: New forms for Notified Bodies in the scope of the MDR and IVDR
- MDCG 2021-19: Guidance note integration of the UDI within an organisation’s quality management system
Neue Benannten Stellen:
Hier sehen Sie die Listen aller benannten Stellen: