Wichtige UDI Links zur EUDAMED
Seit Einführung der MDR 2017/745 und IVDR 2017/746 der Europäische Kommission (EC) stehen Medizinprodukthersteller vor neuen Herausforderungen und grossem Wandel. Folgende wichtige Links und Dokumente helfen dabei die UDI Vorgaben richtig umzusetzen:
EUDAMED Dokumente
- Übersicht Seite Medical Devices EUDAMED
- Homepage EC Medical Devices
- EC-Seite über alles zu den neuen Regelungen
- MDR Regulation 2017/745 of the European Parliament and of the Councial of 5 April 2017 on medical devices
- IVDR Regulation 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices
- EUDAMED Beschluss 2010/227/EU
- Medical Device Coordination Group (MDCG) UDI Guidance
- COMMISSION IMPLEMENTING REGULATION (EU) …/… laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards common specifications for the reprocessing of single-use devices
- Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions (Text with EEA relevance)
EUDAMED Registrierung
- EUDAMED User Guide – Actor Registration Module
- EUDAMED Actor registration module Page
- EUDAMED Actor Roles
- EUDAMED User Access Requests
- Factsheet for Manufacturers 20/11/2018
- EU UDI Helpdesk
GMN Generator für HIBC und GS1