Delegates Flag Concerns Over EU’s Device, IVD Regulations
Delegates from two EU member states raised concerns about compliance timelines for the EU’s new medical device and in vitro diagnostics regulations at a June 14 meeting of ministers from EU member states and senior officials from the European Commission.
Devices certified under the existing legislation can continue to be placed on the EU market under their existing certification up until 2024, but this does not apply to all devices, the delegates from Germany and Ireland said. Existing devices that are “up-classified” or subject to additional regulatory assessments—such as surgical instruments intended to be reused—cannot continue to be placed on the market under their existing certificate up until 2024 and this will lead to market shortages, the delegates said.
The new regulation on in-vitro diagnostic devices does not become fully applicable until May 2022, but it is anticipated that over 80 percent of IVDs will need to be assessed and certified by a notified body before being placed on the EU market, while today more than 80 percent of such devices are self-declared by the manufacturer and do not require notified body certification.