Dive Brief:
- The European Council has signed off on plans to extend the In Vitro Diagnostic Medical Devices Regulation (IVDR) transition, positioning politicians to pass the changes in April.
- Last Wednesday, the Council endorsed changes that the European Commission proposed in January. The proposals include a 31-month extension that would give manufacturers of high-risk devices until the end of 2027 to comply with the IVDR.
- The Council expects the European Parliament to vote on the Commission’s plan, without seeking amendments, in April.
Dive Insight:
The Council endorsement moves the European Union a step closer to enacting changes intended to prevent the risk of the IVDR from disrupting the supply of diagnostics. As the body that sets the EU’s political direction and priorities, representatives of the Council meet with their counterparts from the Parliament to discuss changes to Commission proposals that are acceptable to all three institutions.
Talks between the institutions can take months, but the bodies have moved faster on the Commission’s earlier delays to the IVDR and the Medical Device Regulation. The Council has set the stage for a similarly swift finalization of the latest IVDR proposals by approving the proposals without seeking changes.
In a statement about the approval, the Council said that “many critical IVDs have yet to comply with the new rules, leading to a risk that – once the transition deadline has passed – they may be removed from the market without being replaced.”
The early agreement positions the Parliament to vote to delay enforcement of IVDR compliance more than one year before the current May 2025 deadline for high-risk class D IVDs. The typical 13- to 25-month timeline for certifying high-risk IVDs means companies that are yet to apply to a notified body could miss the current deadline.
Extending the timeline could enable those companies to get certified.
As well as countering the threat to the supply of high-risk IVDs, the Commission’s proposals cover delays to the enforcement of the IVDR for lower-risk diagnostics, steps to accelerate the registration of data on Eudamed, and the introduction of a requirement to disclose interruptions to the availability of some products.