Credit: Flickr, Dimitar Nikolov
Original from: Medtech Dive
The European Union is proposing to delay the go-live date for the incoming medical device regulation pertaining to In Vitro Diagnostics for products that still need assessment of a notified body, its health commissioner said Thursday.
Originally set to go into effect in May 2022, a progressive roll-out is now planned.
¡°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," Stella Kyriakides, Commissioner for Health and Food Safety, said in a statement.
The proposal will now go to the European Parliament and Council for adoption, according to the announcement.
Industry had pushed for years for a delay in implementation in the IVDR¡¯s cousin regulation covering medical devices, but was rebuffed. Things changed when the pandemic hit, and the start date for the new Medical Devices Regulation was postponed a year to May of this year.
Bringing notified bodies online has been a constant source of tension for industry. Under the new rules, these mostly private accrediting organizations had to be recertified, a process that was taking longer than expected and weighed down by competing priorities spurred by the COVID-19 crisis.
With only six such entities certified at the moment, the Commission called the shortage a ¡°grave crisis.¡±
Transition periods will depend on the riskiness of the devices. The highest category for those like HIV or hepatitis tests would be allowed a period until 2025 or 2026, depending. Lower class devices would have until May 2027.
The May 2022 deadline still looms for devices that already have a CE mark and don¡¯t require further notified body coordination.
