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.
Device makers gain more time to adapt to Europe’s MDR after EU vote
The European Parliament on Thursday voted overwhelmingly to delay implementation of the new Medical Device […]
The European Parliament on Thursday voted overwhelmingly to delay implementation of the new Medical Device Regulation or MDR.
The 537-3 vote gives final approval to 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.
Original Article: (https://www.medtechdive.com/news/EU-European-Parliament-MDR-extension/643064/)
