With EUDAMED now mandatory across the EU, manufacturers, importers, and authorised representatives alike are wondering: who exactly needs to register, and by when? Obelis breaks down the requirements clearly, so you know where your organisation stands.
A newly harmonised version of EN ISO 15223-1 introduces the new EU-REP symbol, replacing EC-REP under the EU MDR and IVDR. Learn about the key changes, the transition period until 17 June 2031, and what manufacturers need to do to remain compliant.
The question of when EUDAMED is fully functional has followed the medical device sector for years, through repeated delays and shifting timelines. The status is now clear and the answer has direct consequences for market access in the EU.
An EUDAMED draft is invisible to national competent authorities for compliance purposes. It cannot be referenced in an inspection, it does not satisfy registration obligations, and it offers no regulatory standing in the event of a query.
The window for watching and waiting on IVDR has firmly closed. For manufacturers of in vitro diagnostic medical devices, authorised representatives, and distributors operating in the EU, IVDR operational readiness in 2026 is no longer a future milestone – it is a present obligation.
For manufacturers, authorised representatives, and distributors of medical devices and IVDs in the EU, the May deadline represents the moment when full EUDAMED requirements take effect across all relevant modules. With just 60 days remaining, the time for gradual preparation has effectively passed.
The EU has unveiled a proposal to simplify the MDR and IVDR framework, introducing updates designed to ease compliance and support innovation. Here’s what’s changing and what manufacturers need to do next.
EUDAMED becomes mandatory on 28 May 2026. Discover key deadlines for actor, device, and certificate registrations under MDR and IVDR, and how to prepare.
Since 2024, the European Commission has been conducting a targeted evaluation of the EU Medical Devices Regulations (MDR and IVDR). The Parliament as well as many Member States have called for a simplification of the regulations, together with business associations from the medical device sector.
The EU In Vitro Diagnostic Regulation (IVDR) formally known as Regulation (EU) 2017/746replaces the former…