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

Did You Know?

EU MDR (Europe’s Medical Device Regulation) came into effect on 26 May 2021, twelve months after the original planned Date of Application due to Covid-19 pandemic.

Did You Know?

The Actor Registration module of EUDAMED is already available for production use. The next two modules, for Device Registration (UDI) and Notified Bodies & Certificates, are planned to go-live in September 2021.

Did You Know?

26 May 2021 marks the start of transition arrangements from the former Medical Device Directive (MDD) to new Medical Device Regulation (MDR) until 26 May 2024.

Did You Know?

From 26 May 2024, all certificates issued under the former MDD/AIMDD will become void, if they have not already expired. Certificates that expire between now and May 2024 for products already in the market will need to be recertified under MDR. Any new products placed into the EU markets after 26 May 2024 will need certificates that meet MDR requirements.

Did You Know?

For IVD manufacturers (In Vitro Diagnostic devices), the date of application for IVDR is 18 months after the EUDAMED system becomes fully functional.

Did You Know?

A “fully functional” EUDAMED system is expected to go-live in Q4 of 2022. It is still unclear as to whether this timeline includes the 6 months for system audit before EUDAMED go-live is recorded into the EU Parliament’s journals which marks the official start of mandatory device registration using EUDAMED.