IVDR’s progressive rollout gets official with EU Council, Parliament adoption

Regulatory NewsRegulatory News | 20 December 2021 |  By 

The progressive rollout of the In Vitro Diagnostic Medical Devices Regulation (IVDR) is now official, after the European Parliament and Council adopted an amendment setting new dates of application for some of the regulation’s requirements.
Following significant pressure from industry and facing fears of a market collapse for diagnostics amid the COVID-19 pandemic, the European Commission announced it would delay certain provisions of the IVDR in October. The Commission had previously delayed the application of the Medical Devices Regulation (MDR) by one year in response to COVID-19. (RELATED: IVDR: Commission proposes to delay implementation amid 'grave' notified body shortage, Regulatory Focus 14 October 2021)
“In the midst of an unprecedented public health crisis, we cannot risk shortages of essential medical devices. Health systems and routine health services have been tested like never before. The pandemic has at the same time highlighted the need for accurate diagnostics and a resilient regulatory framework for in vitro medical devices. The amendment of the In Vitro Diagnostic Medical Devices Regulation will ensure that crucial medical devices, such as COVID or HIV tests, continue to be available and safe,” said EU Health Commissioner Stella Kyriakides.
Under the amendment, the regulation’s 2-year transition phase would be extended by 1 to 3 years, with the transition period extending to May 2027 for the lowest risk devices, giving test makers more time to get their products certified and allowing more notified bodies to come online before the regulation takes effect.
The transition period for the highest risk class D devices will be extended to May 2025, while moderate-risk class C devices will have until May 2026 to undergo a conformity assessment for the first time. Class B and Class A sterile diagnostics have until May 2027 to undergo a conformity assessment.
The amendment does not, however, delay the date of application of the regulation itself, which is still set to take effect on 26 May 2022 and will apply in full to CE marked IVDs that do not require the involvement of a notified body. Other aspects of IVDR relating to vigilance and postmarket surveillance will apply to all products covered by the regulation, regardless of whether they are subject to the extended transition period.
“The decision to amend the transitional provisions of the IVD Regulation comes at the last moment to ensure that medical tests can remain available to Europe’s patients and healthcare systems. It is now important that regulators address the remaining critical questions that will support the certification before the end of the new deadlines of more than 32,000 medical tests on the market today, as well as the certification of innovative diagnostics that are in the pipeline and will address unmet medical needs,” said MedTech Europe CEO Serge Bernasconi.
MedTech Europe also took the opportunity to call for “urgent and continued attention by EU regulators” on two outstanding issues: the need for timely guidance on several aspects of the new regulation, and the need for additional IVDR-designated notified bodies.
European Commission


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