Recommendations to avoid a real risk of shortage of essential medical devices

In a statement published today (6 December) the Federation of European Academies of Medicine (FEAM) supports the recommendation of the French National Academies of Medicine, Pharmacy and Surgery and the Royal Academy of Medicine of Belgium (ARMB) to extend the transitional period for the implementation of the EU Regulation 2017/745 by at least two years in order to avoid a real risk of shortage of essential medical devices.

On 31 May 2022, the French National Academies of Medicine, Pharmacy and Surgery and the Royal Academy of Medicine of Belgium (ARMB) alerted the political and administrative world, all healthcare professionals and the patient community to the risk of a shortage of medical devices (MDs), particularly implantable medical devices (IMDs), by 26 May 2024. This risk is real if no measures are taken to overcome the bottleneck constituted essentially by the notified bodies (NBs) responsible for CE marking of these devices in application of the new EU regulation 2017/745, as they are too few in number and have insufficient means. Indeed, any device that is not labelled by this deadline can no longer be marketed and therefore used for the benefit of patients. The FEAM, also concerned by this important public health issue, wishes to endorse this recommendation and has joined the ongoing process.

In the joint document with the three French academies (Medicine, Pharmacy and Surgery) and the ARMB and FEAM list a series of recommendations concerning this challenge:

1. The extension of the transitional period for the implementation of the EU Regulation 2017/745 by at least two (2) years, as already advocated by seven EU Member States.
2. That this extension essentially concerns perfectly proven MDs and IMDs, already CE marked from 1991 to 2021 and for which their manufacturers have expressed the wish to keep them on the market by submitting a validation file, even a partial one.
3. That practitioners using these IMDs should ensure that they are systematically registered in monitoring registers, in relation with the manufacturers responsible for their material monitoring.
4. That the list of essential MDs and IMDs, i.e., those without valid alternatives and not yet registered or in difficulty of registration, be determined rapidly in relation to their users, in order to avoid their disappearance, which would be detrimental to patients’ health.

These recommendation have also been endorsed by the Academy of Medical Sciences of the Serbian Medical Society; the French Academy of Veterinary; the Royal Netherlands Academy of Arts and Sciences (KNAW); the German National Academy of Sciences ‘Leopoldina’ and by the Hungarian Academy of Sciences.

Read the full statement here.