Parliament votes in favor of IVDR legacy extension and EUDAMED mandatory use

On 25 April 2024, the European Parliament voted in favour of the Proposal to extend the transitional provisions for IVDR legacy devices, introduce a gradual roll-out of EUDAMED as well as a notification system for supply interruption of certain critical IVDs or medical devices.

The decision passed with a majority of 511 votes.

New IVDR provisions for legacy devices

The Council of the European Union endorsed the European Commission’s Proposal in February 2024. Similar to last year’s MDR legacy extensions, the Commission proposed to extend the transitional period for IVDR legacy devices to the following dates:

• 31 December 2027 for Class D & devices covered by an IVDD CE Certificate
• 31 December 2028 for Class C
• 31 December 2029 for Class B & A sterile

This prolonged legacy period applies only if the manufacturer takes crucial steps towards the IVDR transition, such as approaching a notified body (by 26 May 2025 for Class D, by 26 May 2026 for Class C and by 26 May 2027 for Class B and Class A sterile devices), and having an IVDR-compliant QMS by 26 May 2025.

EUDAMED roll-out plan and supply interruption notification

The Proposal includes a gradual roll-out of EUDAMED modules. The first modules could become mandatory soon after they were audited and declared functional, which is expected in 2025:

• Actors module (actors shall register within 6 months after the module is declared fully functional)
• UDI/Devices module (devices should be registered within 12 months after the module is declared fully functional)
• Notified Bodies/Certificates module (Certificates should be uploaded within 18 months after the module is declared fully functional)

This would replace the current situation where EUDAMED will only become mandatory once all modules are available. Importantly, it is envisaged that a single registration to EUDAMED will replace multiple national registrations.

Lastly, to prevent market disruptions, manufacturers must give prior notice to EU competent authorities when they foresee the supply interruption of certain critical IVDs or medical devices.

Next step: The Council should now formally approve the text before it can be published in the Official Journal of the EU (expected in May).

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