June 8, 2021

IVDR Compliance: Insights Gained from Writing MDR-Compliant CERs that Can Be Leveraged to Meet IVDR Requirements

Author: Suzanne Broussard, PhD  | June 8, 2021

In vitro diagnostic (IVD) medical device manufacturers are scrambling to meet the In Vitro Diagnostic Regulation (IVDR) 2017/746 requirements imposed by the European Union (EU). Changes in IVD classification will require the majority of IVDs currently marketed in the EU to undergo notified body scrutiny under IVDR and obtain CE marking, yet few guidance documents have been released. Lessons learned from meeting Medical Device Regulation (MDR) 2017/745 can help pave the way.  

Here we share our insights learned from writing many MDR-compliant Clinical Evaluation Reports (CERs) in the context of IVD medical devices and the looming IVDR deadline. 

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May 3, 2021

EUDAMED3 Update: Two More Eudamed Modules Will Be Available Later This Year & Guidance on Alternatives Until the Remaining Three Modules are Released and the Database is Fully Functional

Author: Suzanne Broussard, PhD  | May 3, 2021  

By the end of the year, the first three modules will be accessible on the European medical device database, Eudamed3: Actor Registration, Unique Device Identifiers (UDI)/Device Registration, and Notified Bodies Certificates. The use of these modules is voluntary until all six inter-related modules are ready and Eudamed3 is fully functional. The existing Eudamed2 data base is being overhauled to support the Medical Device Regulations (MDR) and In Vitro Device Regulation (IVDR). 

For more information on the transition from EUDAMED2 to EUDAMED3 see our previous post, The European Commission Pledges Make the Different Eudamed Modules Available On A Rolling Basis.

The six EUMDADED modules are: 

  • Actors Registration 
  • UDI/Devices Registration 
  • Notified Bodies and Certificates 
  • Clinical Investigations and Performance Studies 
  • Vigilance and Post-Market Surveillance 
  • Market Surveillance 

The Actor Registration module became active December 1, 2020. The European Commission has officially confirmed that two more modules will be available by September 2021, the UDI/Device registration (second module) and Notified Bodies and Certificates (third module). Three more modules are scheduled to be displayed as soon as they are functional.  

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June 20, 2018

[FEATURED] Substantial Drop In Certificates Withdrawn By EU Notified Bodies: Why Now?

Data from TEAM-NB, the EU notified body association, shows a big drop in withdrawn certificates from device firms. Does this signal an improvement in the quality of manufacturers’ submissions to notified bodies?

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