For the Symposium’s 10th session on medical devices, we heard from Dr. Antonella Mamoli.
The new regulation on medical devices came into force in 2021, and we are currently in the middle of the transition period, from the old directive to the new European regulation. An important deadline is May 2024: a time when, according to the regulation that came out two years ago, manufacturers will have implemented a QMS (quality management system) that complies with the MDR (medical device regulation) and have requested a conformity assessment from a notified body. The extended transition period will only apply to medical devices that meet certain conditions.
An amendment to the regulation that went into effect in March this year further extended the date by which manufacturers of high-risk medical devices (Class III and Class IIb) must comply with current regulations, setting it at December 2027, and December 2028 for other Class IIb, Class IIa and all other devices. The new regulations seem to have changed so much that the medical device system really needs more time to adjust and update.
To quote Dr. Mamoli, “Italy is a country like any other country in Europe,” meaning that in the process of transitions we are all in the same situation, we are not lagging behind other members of the European Union. One of the problems that manufacturers face at the moment is the lack of production standards, to be used as a reference. This leads to errors and delays in production, before getting the finished product that conforms to the guidelines.
Of course, the Symposium session will be an opportunity to share experiences but also to share doubts and difficulties, there is a need for discussion on the implementation of regulations and interpretation of the current MDR. Many key stakeholders from the medical device industry, as well as Italian health authorities, are expected at the symposium, among whom a useful discussion will surely arise.