European Commission Announces EUDAMED Will be Ready in Q2 2024 – But Can We Believe It? 

Author: Criterion Edge Writers

What You Need to Know 

Already delayed by 4 years, the European Database on Medical Devices (EUDAMED), a European Union (EU) database considered to be the foundation of the EU medical device and in vitro diagnostic regulations (MDR and IVDR), now has an updated timeline for launch, according to the European Commission

Mark Your Calendar  

When the database becomes operational, the following timeline is expected. Of note, it remains uncertain whether EUDAMED modules will have a staggered release.  

  • Q4 2023 
    • Development of Minimum Viable Product (MVP) for all 6 modules to be completed. 
  • Q2 2024 
    • Independent audit will be complete (Q1-Q2 2024) and the system will be fully operational. The audit results will be presented to the Medical Devices Coordination Group (MDCG) prior to launch. 
    • A Commission Notice will be published in the Official Journal of the European Union
    • Once the notice is published, any new data relating to new or existing device must be entered. 
  • Q4 2024 (or 6 months after the publication of the notice) 
    • EUDAMED will become mandatory for the following modules: 
      • Actors 
      • Vigilance 
      • Clinical Investigation & Performance Studies 
      • Market Surveillance 
  • Q2 2026 (or 24 months after the publication of the notice)  
    • EUDAMED will become mandatory for the following modules: 
      • Unique Device Identifiers (UDI)/Device  
      • Notified Bodies (NB) and Certificate 

What Happens Next 

Before EUDAMED becomes mandatory, some may opt for voluntary submission. Three modules are already operational on a voluntary basis: 

  • Actor Registration 
  • NB and Certificates 
  • UDI/Device Registration 

In the meantime, you should continue to comply with reporting requirements specified by the medical device directives. Keep in mind- if this timeline is executed as planned, the timing of mandatory EUDAMED compliance will coincide with that of mandatory MDR compliance (including for legacy products) and with portions of IVDR application, so affected organizations must plan ahead to ensure they are prepared to meet all new requirements.  

Does your organization need support for MDR related submissions including CER, CEP, PMCF plans or reports? Or IVDR related submissions like PER, PEP, SVR, CPR, or PMPF plans or reports? Criterion Edge has the expertise and bandwidth to work with you and get the job done. We have expert medical writers to support your organization in developing the necessary documents to ensure a smooth transition and meet these fast-moving deadlines. Get a free consultation today.

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