In this episode, we discuss the past, present, and future state of EUDAMED. EUDAMED is the European Database for Medical Devices, and is part of the European Medical Device Regulation.
While the EUMDR may have been published in 2017, many companies are still unsure how to handle the submission of their UDI (Unique Device Identification) data.
Joining us to discuss this topic is Richard Houlihan, an international speaker and guest university lecturer on EUDAMED.
His time running the European Commission IT teams developing EUDAMED has given him unrivalled insights into how EUDAMED affects the MedTech industry. This EUDAMED experience and his 28 years in IT give him a real advantage when helping companies prepare for EUDAMED, FDA GUDID, and other regulatory submissions.
His company EirMed with the website eudamed.com provides ongoing EUDAMED and regulatory submission support, training, an EUDAMED mobile search app, and software to help Manufacturers, Importers, European authorised reps, and Distributors meet their EUDAMED obligations.
To date, Richard and his team have trained over a thousand people on EUDAMED and helped hundreds of companies with EUDAMED consultancy and their regulatory data submissions to EUDAMED.
We hope you enjoy this episode on EUDAMED!
Some of the highlights of this episode include:
- After the European Commission's EUDAMED working group meeting in June 2023 and the publication of the minutes, we know that the legally required audit of EUDAMED will now take up to nine months and is to be completed in Q4 2024.
- Six months after the OJEU publication, EUDAMED will be deemed fully functional and EUDAMED will be mandatory. EUDAMED vigilance reporting for serious incidents will be mandatory from that point, Q2 2025 - the day after EUDAMED is fully functional.
- EUDAMED’s fully functional date is now expected to be Q2 2025. Ireland and France have already made EUDAMED mandatory for new products.
- For most medical device manufacturers, EUDAMED’s Actor, Device, and Certificate modules will be the only modules they'll use. These modules are already up and running.
"...it's a hugely ambitious project. Now, the device module and the certificates module, they're both huge in themselves. The vigilance module, that's a whole ecosystem in itself and the clinical investigations for any poor devil involved in clinical investigations, this thing is an absolute monster, it's huge. But what they've done is they're putting them all together and they're connecting them all - in the real world, we would call that consolidation in a marketplace... I was told it was the second biggest It project ever undertaken by the Commission." - Richard Houlihan
- Richard Houlihan
- EirMed (eudamed.com)
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