Combination Product Industry News & Guidance
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EUDAMED will become mandatory for selected modules…
Pharma/Biotech sponsors of co-packaged devices and other separately distributed devices including software as a medical device (SaMD):
For those who have been following the almost decade-long Medical Device Regulation (MDR) transition in the EU – the day has finally come, EUDAMED will become mandatory for selected modules as of May 28, 2026: Actor registration, UDI/Devices registration, Notified Bodies & Certificates, Market Surveillance.
Other modules (such as for clinical investigations, etc.) will follow different timetables as allowed for in a regulation from 2024 that broke apart EUDAMED functionality into different groupings (see article linked in the message below for detail including links to the Commission Decision: 2025/2371 published on Nov 27).
These modules have been available for voluntary usage to-date, so many companies have already registered, however in 6 months it will now be required, and individual countries requiring registration individually should now defer to EUDAMED (more to be confirmed on that front). Additionally, the market surveillance portion may have had more limited voluntary uptake, so I would expect more actions being taken on that front.
What does this mean for you?
This may mean additional registration (e.g. as a distributor or importer for the case of co-packaged devices or as a manufacturer for a SaMD product) beyond what is currently required. Reach out and our experts can help you define necessary next steps.
AUTHOR
Jonathan Amaya-Hodges, Director of Consulting, Suttons Creek – Jonathan has over 16 years of multidisciplinary experience in regulated medical products (drugs, biologics, medical devices, and combination products) at multiple global companies. He has practical experience in Development/Engineering, Quality Assurance, and Regulatory Affairs for various types of combination products with a focus on drug delivery. Additional background includes digital health (including smart packaging/connected devices and software as a medical device, or SaMD) and in vitro diagnostics, along with clinical development (bridging) and lifecycle management for combination products. Jonathan engages with the global combination product community by speaking at conferences, lecturing in courses, serving key roles within prominent industry organizations, and interfacing with regulators on a variety of topics.