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EU Adopts Amendment for IVD Regulation Transition

NEW YORK – The European Parliament and Council have adopted a proposal that will extend the transition periods for different classes of in vitro diagnostics under its new IVD Regulation. The IVDR will still come into effect on May 26, 2022, but manufacturers of tests cleared before that date will have more time to achieve compliance under the new regulation.

Until the EU adopted the amendment this week, IVD makers were expected to have their entire portfolios cleared by designated European certification organizations, called notified bodies, or NBs, by next May. Providers of laboratory-developed tests, called in-house devices in the IVDR, were also expected to be compliant with various new provisions in the regulation.

However, the slow-moving designation of NBs, coupled with challenges caused by the COVID-19 pandemic, made it apparent to most in the industry that if the initial date of application became effective as intended, most of Europe's IVDs might have lost compliance, in essence, overnight.

The EU proposed a phased implementation to avoid such peril in October.

EU Health Commissioner Stella Kyriakides said in a statement this week that the amendment was necessary both because of and in light of the pandemic. "In the midst of an unprecedented public health crisis, we cannot risk shortages of essential medical devices," Kyriakides said. She said the pandemic has "highlighted the need for accurate diagnostics and a resilient regulatory framework for in vitro medical devices."

Under the previous regulation, 1998's IVD Directive, most IVDs reached the clinic via a self-certification process, but the IVDR, adopted in 2017, extended the need for clearance by an NB to the majority of tests in Europe. The shortage of regulatory capacity, though, made it difficult to have all tests cleared by the May deadline. That translated to a potentially dramatic shortfall in compliant tests on the market, should the date of application have remained.

Rather than move the date of application of the IVDR outright, as the EU did in 2020 with the Medical Devices Regulation, the EU decided to retain the May 26, 2022, date, but to extend the grace periods for IVDs, depending on their class. Under the new amendment, devices that did not require a certificate from an NB and obtained their CE-IVD mark prior to May 2022 will remain compliant until May 26, 2025, for class D devices, the highest risk class, which includes diverse tests, such as those for determining viral load and blood-borne diseases.

For medium-risk Class C devices, the same situation will now apply, except that the certificates will be valid until May 26, 2026. Most molecular tests fall into Class C, which covers genetic tests, companion diagnostics, infectious disease tests, and assays for stratifying cancer patients.

Certified Class B and sterile Class A devices holding certificates will remain compliant until May 26, 2027. Class B covers all other devices not covered by Class D and Class C, such as at-home pregnancy tests, and Class A, in general, covers lab equipment, such as reagents and instruments. For in-house devices, the amendment moves the date of implementation of most parts of the IVDR to May 26, 2024, although a provision that requires labs to justify their use of an in-house device instead of a commercial, compliant test, will be deferred until May 26, 2028.

Most notably, the IVDR will still be applied on May 26, 2022. That means that all tests that do not hold CE-IVD certificates will require clearance by an NB under the new rules after that date.