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.