IVDR: Commission proposes to delay implementation amid 'grave' notified body shortage

Regulatory NewsRegulatory News | 14 October 2021 |  By 

Amid concerns of a market collapse and a "grave shortage" of notified body capacity, the European Commission on Thursday proposed to delay the implementation of certain aspects of the In Vitro Diagnostic Medical Devices Regulation (IVDR).
The medical device industry has long pushed for the EU to delay IVDR, warning that the new regulation is more disruptive to the market for diagnostics than its counterpart Medical Devices Regulation (MDR), which itself was delayed by one year a month before its original date of application in May 2020 due to COVID-19. (RELATED: European Commission proposes to delay MDR by a year due to COVID-19, Regulatory Focus 3 April 2020; MDR delay official as industry calls to push back IVDR, Regulatory Focus 24 April 2020)
While EU authorities had long insisted that no such delay would be granted for IVDR, the slow pace of notified body designations and concerns within industry raised the specter of widespread test shortages. So far, just six notified bodies have been designated under IVDR, with 11 applications pending, compared to more than 20 designated under MDR.
A recent industry survey conducted by MedTech Europe also painted a dire picture of the EU's IVD market were IVDR to take effect according to its original schedule. According to the survey, 22% of tests currently on the market would be lost in the transition to IVDR, with many more unlikely or uncertain to be certified in time.
Under the proposal, the regulation's 2-year transitional phase would be extended by 1 to 3 years, with the transitional period extending to May 2027 for the lowest risk devices, giving test makers more time to get their products certified and allowing for more notified bodies to come online before the regulation takes effect.
Specifically, the transition period for high-risk class D devices would 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 would have until May 2027.
The Commission further explains that IVDR itself is not postponed and that the general date of application is still 26 May 2022 and that it "will apply in full … to CE marked in vitro diagnostic medical devices that do not require the involvement of a notified body." Such devices include class A non-sterile devices and new IVDs that are not covered by a certificate or a manufacturer's declaration of conformity issued prior to IVDR's entering into force.
The Commission also notes that manufacturers will still have to adjust to certain aspects of IVDR next year, such as the enhanced requirements for vigilance and market surveillance, even if their products are otherwise subject to the extended transition period.
"The COVID-19 pandemic has shown how essential it is to have accurate diagnostics and a robust regulatory framework for in vitro medical devices. Shortages at this point in time are unthinkable. The pandemic has imposed unprecedented challenges also for our medical devices industry. With more time to prepare for the application of the EU new rules, we will ensure there is a continuous supply of essential in vitro diagnostic medical devices on the market, while not compromising on safety. I call on all manufacturers to prepare for certification under the new Regulation as soon as possible and not wait until the end of the transition period," said EU Health Commissioner Stella Kyriakides.
In response to the proposed delay, MedTech Europe said, "It is important that the European Commission seeks to safeguard the availability of in vitro diagnostic tests to patients and healthcare systems, particularly in a challenging pandemic situation, while transitioning into the Regulation." The group also noted that stakeholders must now assess the proposal to ensure it will "address the critical implementation challenges at stake for an efficient and successful transition.
The proposal now heads to the European Parliament and Council for adoption and will take effect upon publication in the Official Journal of the European Union.
Statement, Proposal, Q&A


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