Following the European Commission’s EUDAMED working group meeting in June 2023 and the publication of the minutes, we now have a clearer picture of EUDAMED’s future. The minutes of the meetings state that the legally required audit of EUDAMED will now take up to nine months and be completed in Q4 2024.

A notice will then be posted in the Official Journal of the European Union (OJEU) stating that EUDAMED is ready and considered functional. This starts the clock running, six months after the OJEU publication EUDAMED is deemed fully functional and EUDAMED is mandatory. EUDAMED vigilance reporting for serious incidents will be mandatory from this point, Q2 2024.

The Audit is interesting, it was always expected this audit would take three to six months. It now appears that the EUDAMED team are buying themselves at least six months of contingency. By starting the audit three months later and adding three months to the audit length we get an additional six months bringing us to Q4 2024.

I think extending the audit is a good thing, the EUDAMED test teams can use this time to stress test the application as the functional testing will have finished. They can also make sure the application is secure with full cyber security or penetration testing. When the application goes to audit all development will be finished so functional testing will be no longer needed whereas stress and penetration testing are most definitely needed.

EUDAMED’s fully functional date, based on the minutes of the meetings will now be Q2 2025. Do not let the time from now until then give you or your company a false sense of security. Ireland and France have already made EUDAMED mandatory for new products. Finland, for Finnish originating medical device companies EUDAMED is also already mandatory. More competent authorities will follow suit.

For the majority of medical device manufacturers, EUDAMED’s Actor, Device, and Certificate modules will be the only ones they ever use. These modules are working perfectly right now. EirMed (eudamed.com) has successfully uploaded thousands of devices for many clients. These companies are complete, their catalogues are uploaded, and the worst of the EUDAMED project is now complete. There is no reason to delay adding your devices to EUDAMED, this has to happen regardless of EUDAMED’s fully functional date.

We are now in the 2024 budget season, for most, it is now you are submitting your budget requirements for 2024. Because of the time it takes to get the EUDAMED data collated and submitted to EUDAMED I strongly advise you to budget for your 2024 EUDAMED project, if you haven’t already started it. This project should be started at the latest in Q1 2024, if you can it should be started now.

EirMed and our partners can help you. The EUDAMED project involves gathering the correct data, validating it against EUDAMED rules, and submitting it to EUDAMED. Next, you will require SoPs for EUDAMED management and maintenance. We can manage this entire project for you, from start to finish, without your team’s day jobs being disrupted for months.

EUDAMED is ready for your UDI Device data now, please do not delay.

💥Special offer:💥 New subscribers to our EUDAMED submission software will receive 📣“FREE” access to our self-paced ‘EUDAMED Simplified’ training.

Minutes June 2023: MDCG and EUDAMED working group

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