European Council backs delay to Medical Devices Regulation (MDR) deadlines 12 Dec 2022
The Regulatory Affairs Professionals Society (RAPS) reports that the European Council supports a proposal made by the European Commission to delay the transitional deadlines for medical devices under the MDR.
In a session held on 9 December 2022, European health commissioner Stella Kyriakides noted that market readiness had been impacted by the COVID-19 pandemic, raw materials shortages and low notified body capacity.
She suggested that the deadline for higher risk class III and class IIb devices be extended to 2027, and the deadline for lower risk class I and class IIa devices to 2028.
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