Manufacturers, Take Note!
The EUDAMED portal has been in development since 2017 and has already been made accessible to users to a large extent. However, the registration of medical devices via EUDAMED has been voluntary until now.
The EUDAMED-Portal ist seit 2017 in der Entwicklung und wurde schon zu großen Teilen Nutzer*innen zugänglich gemacht. Allerdings war die Registrierung von Medizinprodukten über EUDAMED bislang freiwillig.
That is about to change. In this article, we explain the complicated consequences of the EU legislation in simple terms and provide recommendations for manufacturers..
In short: Manufacturers are advised to register all products via EUDAMED with immediate effect.
But What Exactly Does the Law say About EUDAMED?
Article 123, paragraph 3 sets out the transition periods for the implementation of the law. This shows that there are five milestones before the EUDAMED system becomes fully mandatory:
- From 2017: Development of the EUDAMED system
- 18 June 2025: Full functionality of all four modules of the EUDAMED system is confirmed by an audit. From this point onwards, EUDAMED is de facto fully operational.
- 27 May 2026: According to Article 123(3), all products placed on the market for the first time after this date must be registered directly via EUDAMED. This corresponds to six months after the publication of the Commission's communication.
- 27. Mai 2026: Gemäß Artikel 123, Abs. 3 müssen alle Produkte, die nach diesem Datum erstmalig in Verkehr gebracht werden, direkt über EUDAMED registriert werden. Dies entspricht sechs Monaten nach der Veröffentlichung der Mitteilung der Kommission.
- 27 November 2026: By this date, all products placed on the market for the first time or on an ongoing basis must be registered with EUDAMED. Products without EUDAMED registration will no longer be eligible for authorisation from 27 November 2026 onwards.
What Does this Mean for Manufacturers?
As product registration via EUDAMED will become mandatory in any case, BEO BERLIN strongly recommends that manufacturers should endeavour to register their products with immediate effect.
For products that have not yet been placed on the market, EUDAMED registration makes sense from the outset because it saves manufacturers from having to do the same work twice: the product would have to be registered with EUDAMED within a year anyway.
For products that have already been placed on the market but are not yet registered with EUDAMED, it makes sense to plan and implement the new registration now – because it will become mandatory in a year at the latest. There is still plenty of time to collect the necessary product data and restructure it if necessary.
Please also visit our YouTube channel! We have already published two tutorials on the EUDAMED registration process.
Pro Tip: Work with Experts!
The text of the law alone, although simple in content, is structurally and syntactically a real headache. The same applies to the requirements for EUDAMED.
Legislative language can be tricky for manufacturers who specialise in developing innovative and reliable medical devices rather than interpreting legal jargon.
BEO BERLIN is there for precisely such cases: for 25 years, our team of professional regulatory affairs experts has been working with manufacturers to find pragmatic, legally compliant ways to place medical devices on the market and in the medical aids directory.
Get in touch with us and work with us to make your products future-proof!
We look forward to see you!
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