The European Commission is considering extending the transition period for compliance with the In Vitro Diagnostic Medical Devices Regulation (IVDR) due to concerns that manufacturers might not have sufficient time to comply. The IVDR came into force in May 2022, and the transition periods were previously extended in 2021 to May 2025 for high-risk devices, May 2026 for moderate-risk devices, and May 2027 for lower-risk devices. The Commission aims to provide more time for manufacturers, especially for high-risk devices critical for testing infections in blood and organ donations.
Under the proposed extension, high-risk class D diagnostics would have until December 2027 to undergo conformity assessment, class C tests until December 2028, and low-risk class A and B tests until December 2029. The proposal emphasizes the need for companies to notify authorities six months in advance of potential interruptions in the supply of diagnostic devices.
The European Commission is also proposing to accelerate compliance with EUDAMED requirements, making certain modules mandatory by late 2025. EUDAMED is crucial for monitoring potential product shortages in the EU market and preventing duplicate product registrations. The proposal suggests mandatory adherence to EUDAMED modules after they have been audited and declared functional, starting in the fourth quarter of 2025.
Manufacturers are urged to utilize the extended timeframe effectively, with the Commission emphasizing the importance of EUDAMED in improving transparency and providing information on devices in the EU market. Challenges with EUDAMED data entry and software functionality have been acknowledged, but the proposal aims to address these issues.
Notified bodies have supported the Commission by providing data, but the proposal seeks prospective information on devices that may disappear from the market. Stakeholders are urged to believe in and work toward compliance with the new regulations. The Commission will present its proposed IVDR revisions to the European Parliament and Council, initiating preparatory work for the targeted evaluation of medical devices legislation, assessing its impact on device availability, costs, and administrative burdens, particularly for small and medium-sized enterprises (SMEs). Both the EU Commission and the NBs warn not to delay compliance with the IVDR with these new extensions.
For more information, the full report from the European Commission can be found below.
IMMC.COM%282024%2943%20final.ENG.xhtml.1_EN_ACT_part1_v4.docx (europa.eu)
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Ava Carr – Content Creator