With EUDAMED now mandatory across the EU, manufacturers, importers, and authorised representatives alike are wondering:…
IVD’s
Is EUDAMED Fully Functional? Latest Live Date Updates & Final Preparation Steps
The question of when EUDAMED is fully functional has followed the medical device sector for…
Why EUDAMED Draft Status Offers Zero Legal Protection After May 28
The assumption is understandable: data has been entered, the system has accepted it, something is…
IVDR Readiness in 2026: Why Delayed Operational Setup Creates Major Risks
The window for watching and waiting on IVDR has firmly closed. For manufacturers of in…
How to Approach the Final Days Before the EUDAMED 2026 Deadline in May?
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.
EU Proposal to simplify MDR and IVDR: what it is and why it matters
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: deadlines for actor, device, and certificate registrations
EUDAMED becomes mandatory on 28 May 2026. Discover key deadlines for actor, device, and certificate registrations under MDR and IVDR, and how to prepare.
Revision of the Medical Devices Regulations in the EU
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.
September 2025 deadline for IVDs in the EU: signed agreement for class D legacy devices
Manufacturers of Class D IVDs must sign an agreement with a notified body by 26 September 2025 to benefit from IVDR transitional periods. Learn about the deadlines, requirements, and how Obelis supports the process.
Legacy requirements: 26 May 2025 deadline for in-vitro diagnostic medical devices in the EU
Legacy in-vitro diagnostic devices must comply with IVDR by 26 May 2026. Learn key deadlines, QMS requirements, and how Obelis can support your transition.