MDR OVERVIEW
What is EU-MDR (Medical Device Regulation)?
MDR Eudamed is the new European Databank on Medical Devices. Eudamed has been in existence for many years but only accessible by the European Commission and the National Competent Authorities. Eudamed 2 has been processing device, certificates, NCARs and clinical investigations data for many years. It came into force in May 2011 (Regulation (EU) 2017/745).

MDR Eudamed Application Scope
New medical device regulations were adopted in 2017 by the EC, which include provisions to create a new application MDR Eudamed. This application is far larger and more ambitious than the previous application.
The application will manage the data for:
- Devices (Unique Device Identifiers (UDI)
- Certification (e.g. CE markings)
- Clinical Investigations
- Manufacturers and importers — identified by a Single Registration Number (SRN)
- Notified Body accreditation and designation
- Extended vigilance data, including post-market surveillance
- Applications for conformity assessment by Notified Bodies
- Summaries of safety and clinical performance
- Performance studies for IVDs (like clinical investigations)
- Market surveillance data