In November 2024, the Medical Device Coordination Group (MDCG) published a Q&A document Gradual roll out of EUDAMED. This document addresses practical issues related to the phased implementation of EUDAMED under the MDR and IVDR. It covers the gradual introduction of EUDAMED, the requirement to notify authorities about supply interruptions or discontinuations, and the transitional provisions for certain in vitro diagnostic medical devices (IVDs).
The publication is divided into three sections:
- Part A – Gradual Roll-Out of EUDAMED (Article 34 MDR)
- Part B – Transition Periods for Mandatory Use of EUDAMED (Articles 123 MDR and 113 IVDR)
- Part C – Transition Periods for Each EUDAMED Module
EUDAMED consists of six modules:
- Actor Module
- UDI/Device Module
- Notified Bodies and Certificates Module
- Post-Market Surveillance and Vigilance Module
- Market Surveillance Module
- Clinical Investigations/Performance Studies Module
Among these, the Actor Module is the most critical. Currently, not all modules are fully operational, and their use remains voluntary. Additionally, the document Gradual Rollout of EUDAMED has not been formally endorsed by the European Commission, and registration in EUDAMED is not mandatory at this stage.
To ensure patient safety and public health, manufacturers and notified bodies have been granted extended timelines to complete conformity assessments for in vitro diagnostic medical devices (IVDs) under the IVDR.
