On February 16, 2023, the European Parliament cast its favorable vote on the transitional provisions for medical devices and IVDs, as stated in the approved text, and available at the following link:
Despite the constant increase in the number of notified bodies designated in compliance with Regulation (EU) 2017/745, the overall capacity of the organisations notified is not yet sufficient to guarantee the conformity assessment of the large number of devices covered by certificates issued in accordance with the Directive 90/385/EEC or Directive 93/42/EEC by 26 May 2024.
In light of warnings from healthcare professionals about the imminent risk of shortages of devices, it is urgently necessary to extend the validity of the issued certificates in accordance with directives 90/385/EEC and 93/42/EEC, as well as the transitional period during which devices complying with these directives can be legitimately placed on the market.
Let see what these transitional provisions consist of:
🔹 Provide more time to notified bodies designated to ensure manufacturers a correct assessment of
the conformity of their devices;
🔹 Extend the validity of certifications already issued in conformity of directives 90/385/EEC and 93/42/EEC.
Reading the text carefully, a point emerges that arouses great interest in manufacturers, point 6): the extension should be subject to certain conditions to ensure that only devices that are safe and for which manufacturers have taken measures to transition towards compliance with Regulation (EU) 2017/745, benefit from the additional time.
What does this mean? That manufacturers are given more time depending on the fact that they have made changes to the technical documentation or that they must have made the request for transition to the new Regulation? What happens in the particular case in which the Notifying Body of the manufacturer has not yet received notification from the EU to validate the devices according to regulation2017/745?
Many manufacturers today find themselves in the position where if their Notifying Body has not received notification of their Regulations and requests for transfer to other Bodies, which are instead notified, are rejected, their requests suffer significant delays due to the fact that the Institutions are unable to make up for the high demand for assessments.
A point that has not yet been clarified by the competent ministries.