The European Parliament on Thursday voted overwhelmingly to delay implementation of the new Medical Device Regulation, or MDR.
The 537-3 vote approves a plan adopted by the European Commission in January to extend deadlines for compliance with new rules for certifying medical devices.
The new timeline depends on a device’s risk class and is being implemented to ensure patients have continued access to medical technologies, according to the Commission. Devices placed on the market under the current legal framework can remain on the market, it added.
European officials extended the initial MDR deadlines in response to the COVID-19 pandemic and allowed devices with valid certificates under the old directives to stay on the market until 2024.
The revised plan, giving companies more time to certify medical devices, is intended to mitigate the risk of shortages by introducing a longer transition period to adapt to the new rules. Manufacturers now have until 2027 or 2028, depending on risk classification, to get their devices designated under MDR.
