0960/2022

Summary title: Petition No 0960/2022 by L.F.C. (Polish) on Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices

Petition number: 0960/2022

Topics: Health

Country: European Union

Name: E. P.

The petitioner calls for a change of approach as regards the requirements laid down in Regulation (EU) 2017/745 on medical devices (Medical Device Regulation). He claims that the Medical Device Regulation is damaging to the European medical technology industry, and that it leads to unfair treatment for European citizens. The alleged reasons for that damage are: the high costs of Medical Device Regulation certification (which are far higher than for the current Medical Device Directive certification) and a lack of technical capacity to conduct the certification process in such a short timeframe for such a large number of products. According to the petitioner, the tightening-up of the Medical Device Regulation will lead to the withdrawal of devices from the market, which would result in a risk of shortages of medical devices in treatment units. The petitioner also considers that the high cost of certification will significantly increase the cost of treatment. The petitioner therefore calls for an extension of at least 3 years in the final deadline for the Medical Device Regulation transition period and for urgent action to reduce the costs of certification processes, and finally for a relaxation of the medical device certification requirements for groups of medical devices already on the market, or so-called ‘legacy devices’.