Council adopts IVDR legacy extension and sooner mandatory use of EUDAMED

On 14 February 2024, the Council of the European Union endorsed the European Commission’s proposal for a gradual roll-out of EUDAMED as well as for extending the transitional provisions for IVDR legacy devices without any amendments. With the approval of the Council of the European Union, this proposal is expected to be formally adopted by both institutions following the legal-linguistic revision. As mentioned in a previous post, this proposal includes:

Extended transitional period for IVDs

Due to similar challenges faced by MDR legacy devices, the Commission proposed to extend the transitional period for IVDR legacy devices to the following dates:

  • 31 December 2027 for Class D
  • 31 December 2028 for Class C
  • 31 December 2029 for Class B & A sterile

This prolonged legacy period will apply only if the manufacturer is taking necessary steps towards the IVDR transition, such as approaching a notified body and having an IVDR-compliant QMS by 26 May 2025.

EUDAMED gradual roll-out

Regarding EUDAMED, the EC’s Proposal introduces the mandatory use of EUDAMED modules as soon as they become available, instead of the current situation where EUDAMED will only become mandatory once all modules are available. In this sense, the mandatory use of the following modules could be expected by the last quarter of 2025:

  • Actors module
  • UDI/Devices module
  • Notified Bodies/Certificates module

National registration will be substituted by the single registration to EUDAMED.

Finally, the proposal also includes provisions obliging manufacturers to inform the relevant competent authorities and health institutions before they stop the supply of medical devices in the market.

Do you want to know more about the IVDR and MDR transitional period? Contact us now!

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