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

 

GMN Generator für HIBC und GS1

• GS1 Global Model Number (GMN) – Basic UDI-DI Generator

• HIBCC Basic UDI-DI Generator 

 

DUNS Nummernsuche

• Unique Partner Identification Key (UPIK) DUNS Identifier 

 

Notified Body Suche

• New Approach Notified and Designated Organizations (NANDO)