Regulation (EU) 2023/607, that has been adopted in March 2023, amends the transitional provisions for certain medical devices covered by the Medical Device Regulation (EU) 2017/745 (MDR). The transitional provisions were introduced in order avert any risk critical medical devices shortages in the EU market and to help with the limited capacity of the notified bodies. On paper, the extension has given manufacturers additional time to achieve MDR compliance, that being said, this will be subject to a number of pre-conditions that have to be met.
Since the time of the introduction of this new amendment, many actors within the medical device regulatory space have voiced their opinion on the matter. All in all, we would say that the extension has been well received.
Team Notified Body has released a position paper in which they state their position relating to the current state of affairs of this amendment. The paper includes many aspects relating to the new timelines, risk of medical device shortages, number of applications submitted and notified body capacity.
The position paper can be accessed using the following link
