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 &…
With EUDAMED obligations becoming enforceable from 28 May 2026, manufacturers and economic operators should already be preparing for upcoming registration and compliance requirements under MDR & IVDR. During this expert-led session, our speakers will provide practical insights into the EUDAMED regulatory framework, key timelines and deadlines, affected economic operators, MDR & IVDR registration requirements including…
Starting on 31 July 2026, cosmetic products placed on the EU market must comply with the updated labelling requirements, including the disclosure of 56 additional fragrance allergens where applicable. From this date onwards: ✅ Products that do not meet the updated labelling requirements may be held at customs, refused entry, or removed from the market…