IVDR launch date potentially postponed
The In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 is scheduled to be implemented for May 26, 2022. Many European biotech companies and Medtech Europe, the association for medical device manufacturers in Europe, already asked for a postponement on July 9, 2020 and urged the European Commission, Member States and the European Parliament to enact solutions for the postponement of deadlines. If the deadline would be implemented on the scheduled date May 26, 2022, more than 21% of the tests would be lost in the transition of the IVDR.
Now the European Union proposed to delay the date for products that would require an assessment of Notified Bodies. Due to the slow pace of designations of notified bodies, that had to be recertified due to the new rules and the effects of COVID-19 causing overload on medical device companies and notified bodies, would not make it realistic to keep the deadline in place.
Transition periods will depend on the riskiness of the devices. 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.