The progressive implementation of the European Database on Medical Devices (EUDAMED) represents a major regulatory milestone for manufacturers of medical devices and in vitro diagnostic products operating in the European Union. From May 2026, the mandatory use of key EUDAMED modules will introduce new obligations under both the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR).
This event provides a comprehensive overview of the upcoming EUDAMED requirements and offers practical guidance on how manufacturers can prepare to meet these obligations effectively and on time.
Participants will gain clarity on the scope and impact of EUDAMED, including economic operator registration, device and UDI registration, the role of notified bodies and certificates, and the implications for market surveillance activities. The session will also address common challenges faced by manufacturers and outline strategies to ensure regulatory compliance and business continuity.
The event is coordinated by Asphalion experts Fran Rodríguez and features Diego Sanoja as a speaker. In addition, the agenda includes Manel Martínez from AECOC, providing an industry perspective that complements the regulatory viewpoint. Together, the speakers will share practical insights and best practices to help manufacturers adapt their regulatory strategies to the EUDAMED framework.
This event is particularly relevant for regulatory affairs, quality and compliance professionals, as well as manufacturers and authorised representatives responsible for MDR and IVDR compliance and EUDAMED submissions.
Registrations are now open.
To view the full programme and secure your place, please register via the official event page:
https://aefi.org/eventos/eudamed-2026-como-cumplir-con-las-nuevas-obligaciones-para-fabricantes-de-productos-sanitarios-y-productos-sanitarios-de-diagnostico-in-vitro/
Need further help or information for EUDAMED or regulatory compliance? Contact us: [email protected]
