- The European Commission has proposed another extension to the deadline for compliance with the In Vitro Diagnostic Medical Devices Regulation (IVDR), a new regulatory framework for diagnostics like HIV, cancer and COVID-19 tests.
- Amid fears the current timelines will disrupt supply, officials are planning to give manufacturers another 31 months to get tests certified under IVDR. The delay, which was proposed Tuesday, pushes the deadline for high-risk class D IVDs to the end of 2027.
- The commission shared details of the timeline alongside news of its intent to make use of the Eudamed database mandatory earlier than planned and to conduct a “targeted evaluation” of the device legislation. MedTech Europe welcomed the proposal to evaluate the laws.
The European Union originally planned to enforce IVDR starting in May 2022. However, concerns that some tests would lack IVDR certificates by that date prompted officials to create a new staggered timeline in October 2021. The revised timeline gave manufacturers of high-risk class D IVDs until May 2025 to comply.
Because it generally takes between 13 and 24 months to certify class D devices, manufacturers that haven’t yet applied to a notified body may be unable to comply with the May 2025 deadline. MedTech Europe is among the organizations that raised concerns about the class D timeline and proposed ways to cut the risk of IVDR disrupting the supply of tests.
The commission has recognized the threat, noting that “a high number of IVDs currently on the market has not factored in the new rules (nor has been replaced by other devices), meaning that those devices would no longer be available.” Officials said the number of noncompliant class D IVDs is particularly high.
In response, the commission has proposed a 31-month delay that would push the deadline for high-risk devices to the end of 2027. The proposed deadlines for medium and lower-risk IVDs would be at the end of 2028 and 2029. Health institutions that manufacture IVDs in-house would have until May 26, 2030, to show that there is no alternative and equivalent commercial device on the market.
As part of the delay, the commission plans to require manufacturers to give prior notice if they foresee an interruption to the supply of IVDs or medical devices. MedTech Europe has asked for the notification process to “be as administratively simple as possible” and managed at the EU level.
The trade group is also pushing the commission, the Medical Devices Coordination Group and notified bodies to use the time created by the delay to “identify blockages and rectify existing issues, to enable all manufacturers to transition on time and meet post-market requirements.”
MedTech Europe, which previously pushed for “comprehensive structural reform” of IVDR and the Medical Devices Regulation, the new regulatory framework for oversight of devices that are not diagnostics, welcomed the commission’s plans to prepare for a “targeted evaluation of the legislation” this year. Officials plan to assess how the legislation is affecting the availability of devices, paying particular attention to products for children and rare diseases, innovative devices, and the costs and administrative burdens imposed on smaller companies.
The commission proposed the new timelines, which will now go to the European Parliament and Council for adoption, alongside plans to speed up the launch of parts of the Eudamed database that are already finalized, with a view to making use of the modules mandatory from late 2025. MedTech Europe and other groups have set five conditions they want Eudamed to meet before use becomes mandatory, including eliminating redundancies in national databases and creating a “realistic and reliable” implementation timeline.