Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the phasing-in of Eudamed, the information obligation in case of supply disruption and the transitional provisions for certain in vitro diagnostic medical devices

1. Proposal to further extend the transitional period for certain IVDs
   Similar to the MDR approach for medical devices, the extension should be linked to conditions that ensure that only manufacturers who actively take/have taken the necessary steps to switch to the new regulations benefit from the additional period. By 05/2025 at the latest, all manufacturers must also have set up a QM system in accordance with Article 10 (8) IVDR.
   
   
   
2. Obligation to use individual modules of the EUDAMED database at an early stage (no more postponement until all modules are functional).
   
   With a gradual implementation of EUDAMED, the mandatory use of several modules could then begin as early as Q4/2025. With the initial mandatory use of all 6 modules, EUDAMED would not be expected to be operational before Q2/2029, taking into account the planned deadlines.
   
   
   
3. Obligation for manufacturers or authorised representatives to report possible supply shortages of medical devices

You can find out more here:

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM%3A2024%3A43%3AFIN&qid=1706001397737