Our calendar informs on industry events, upcoming compliance deadlines, as well as new Obelis webinars.
As the transition to the In Vitro Diagnostic Regulation (IVDR) continues, we would like to remind you of the critical 2026 deadlines for legacy IVDs that are classified to Class C under IVDR. For these devices, the following milestones apply: ✅A written agreement between the manufacturer and the Notified Body must be signed by 26 September 2026. ✅The manufacturer or their Authorised…
Regulatory Alert | EUDAMED becomes mandatory Commission Decision (EU) 2025/2371 confirms the full functionality of the first four EUDAMED modules. As a result, economic operators must comply with mandatory registration requirements. Mandatory modules from 28 May 2026: ✅Market Surveillance ✅Actors: registration of manufacturers, authorised representatives, importers ✅UDI / Devices: device registration (excluding custom-made devices) ✅Notified Bodies &…