European Council members expressed support for a proposal by the European Commission to delay the transitional deadlines for medical devices under the Medical Devices Regulation (MDR). Members said they are concerned there isn’t enough capacity to handle all the thousands of outstanding conformity assessments that must be completed before the transitional period provided in Article 120(3) of the regulation expires and fear the current deadlines could trigger widespread shortages if left in place.
Stella Kyriakides, the European health commissioner, proposed postponing the MDR transitional deadlines during a 9 December session of the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) in Brussels. She urged the Council and the European Parliament to extend the deadline for higher risk class III and class IIb devices to 2027 and the deadline for lower risk class I and class IIa devices to 2028…
