Important UDI links to EUDAMED

Since the introduction of MDR 2017/745 and IVDR 2017/746 of the European Commission (EC), medical device manufacturers have been facing new challenges and major changes. The following link list and documents helps you to implement the UDI requirements correctly:

EUDAMED Documents and links

• Overview Medical Devices EUDAMED
• Medical Devices -EUDAMED
• Medical Devices – New Regulation
• 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 
• EUDAMED Timeline (Update June 2022)
• EMDN Code search (European Medical Device Nomenclature Code search)
• 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 Registration

• EUDAMED User Guide – Actor Registration Module 
• EUDAMED Actor registration module Page
• EUDAMED Actor Roles 
• EUDAMED User Access Requests 
• Factsheet for Manufacturers 20/11/2018
• Contact to EUDAMED Helpdesk
• Login zur EUDAMED Produktiv
• Login zur EUDAMED Playground (Test envirement)

GMN Generator for HIBC, GS1, IFA

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

 

Number Search

• Unique Partner Identification Key (UPIK) DUNS Identifier 
• EUDAMED Actor Search (SRN Search)

Notified Body Search

• New Approach Notified and Designated Organizations (NANDO)