In brief
Following concerns expressed about the capacity of Notified Bodies to certify medical devices in accordance with the EU Medical Device Regulation (MDR) within the transitional periods provided therein, on 6 January 2023 the European Commission adopted a proposal to extend the transitional periods under Article 120(3) of the MDR.
Key takeaways
The proposal does not change any of the current safety and performance requirements of the MDR and only amends the transitional provisions with staggered deadlines, depending on the risk class of the medical device. In particular, it is envisaged that class III devices and class IIb implantable devices may continue to be placed on the market until 31 December 2027, whereas for class IIb, class IIa and class I devices placed on the market in sterile condition or having a measuring function, the deadline is extended to 31 December 2028.
In order to benefit from these extensions, the relevant devices will have to fulfil specific conditions, including compliance with the provisions of the MDD and AIMDD Directives, shall not be subject to significant changes in design and intended purpose, and shall not represent an unacceptable risk to human health.
The proposal needs to be adopted by the European Parliament and the Council through an accelerated co-decision procedure.
