September 13, 2022

MDCG 2022-12: “Alternative Solutions” Document. Interim Guidance for IVD Manufacturers  

Author: Criterion Edge Writers

What You Need to Know  

The Medical Device Coordination Group (MDCG) released a new document (MDCG 2022-12) to establish guidelines for in vitro diagnostic medical device (IVD) manufacturers while the EU awaits the European Database on Medical Devices (EUDAMED), a project that was scheduled to be completed years earlier than its now-projected date of Q2 2024.  

Do you like it?0
September 6, 2022

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.  

Do you like it?0
December 14, 2021

[FEATURED] Timelines And Deadlines For Stakeholders To Submit Information To EU’s Eudamed Database

IT system deadlines are renowned for being delayed. With speculation that the full implementation of the Eudamed medical device database will be postponed again, what will this mean for stakeholders?

The timelines and deadlines for uploading information into the upgraded Eudamed database have never been easy to understand. Indeed, the complex wording and cross-referencing in Articles 123 and 113 of the Medical Device Regulation and IVD Regulation, respectively, have perplexed even the experts and lawyers over the years.

Gradually, light has been shone on Eudamed’s intricate web of compliance conditions, and the Medical Device Coordination Group has issued guidance. But in parallel, it has also emerged that there are now likely to be problems with the European Commission managing to launch the full system on its 26 May 2022 anticipated go-live date (already itself delayed by some two years compared with the date originally set).

Do you like it?0
December 7, 2021

[FEATURED] Are Latest Challenges Threatening To Push Eudamed Launch Date Into 2023?

While nothing is official yet, it seems that the EU is likely to struggle to have two of the six Eudamed modules ready on time. Might this mean a further delay, or will the system be officially launched without them? 

The clinical investigations and the market surveillance modules of the new version of the EU medical device database, Eudamed, are reported to be causing the biggest challenges when it comes to setting up all six modules so that the entire database can be launched in 2022.

“We may even see Eudamed being launched officially with one or both missing, Ronald Boumans, senior consultant, regulatory affairs Emergo by UL, speculated.

Do you like it?0
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.  

Do you like it?0

[Free Webinar] Developing Effective Patient-Focused Content: Writing Plain Language Lay Summaries and SSCP Patient Sections  

Join us on Wednesday, April 5th, 2023 at 11 AM PST, as our experts discuss best practices to guide the development of common forms of plain language communication intended for the patient and their families and/or caregivers.  

Spots are limited – click to register for this free webinar.

Check out our Events Calendar for our upcoming webinars.

Named the #1 Regulatory Services Company 2022 by Life Sciences Review