EU Parliament Votes “Yes” to Extend IVDR Transition Period & Gradual Rollout of EUDAMED
25 April 2024
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27 April 2024MDCG “Extraordinary” Meeting
On 24 April 2024, the MDCG met to discuss:
- How to coordinate and handle potential supply shortages that result from the May 26, 2024 MDR deadline, and
- Commission proposal COM(2024)43, which is the proposal to 1) extend the IVDR transition, 2) rollout EUDAMED in phases, and 3) require manufacturers to inform stakeholders of anticipated disruption to the supply of critical products.
The MDCG meeting agenda is available: HERE
The aim was to:
“…provide a space for national competent authorities to share relevant information, including discussing the practical steps to follow in view of the 26 May 2024 deadline (Regulation (EU) 2023/607) and potential device discontinuations.”
As well:
“…competent authorities are encouraged to share information and to discuss the practical steps for sharing information on discontinuations of medical devices during the transitional period before the proposed art. 10a COM(2023)43 [sic] becomes applicable, pending its adoption.”
And, to receive an update on the “study on monitoring availability of medical devices”.
Transition to the MDR/IVDR has been fraught. The Commission is greatly concerned about a shortage of devices in Europe, and the potential negative impact on patient care.
This is why they 1) built the dashboard monitoring availability of devices on the market, 2) are requiring advance notice of potential device shortages, and 3) are pushing forward the EUDAMED device registration requirement, to better understand exactly which devices are on the market.
The meeting minutes have not been published, to understand resulting actions, if any.
More on Commission Proposal COM(2024)43 is available here: EU Parliament votes “yes” to extend IVDR Transition Period & Gradually roll-out EUDAMED
New “Have your say” Initiative for the MDR/IVDR
The Commission is planning a public consultation on the state of the MDR and IVDR. The initiative is outlined: HERE
This includes requesting feedback confirming if the new Regulations:
- Are effective, efficient and proportionate
- Meet current and emerging needs
- Align with other actions
- Have EU added value
This is an opportunity for industry, including small-to-medium enterprises, to provide feedback. E.g., if they find the new Regulations “effective, efficient, and proportionate”.
Casus will report once the consultation is live. It is currently planned for Q3 2024.
