"Legal measures should be implemented early, preferably this year, to re-establish confidence in the system of market access and market surveillance", stated BVMed CEO and Member of the Board Joachim M. Schmitt in a letter to Health Commissioner Tonio Borg.
According to BVMed, the following proposals should be extracted from the Medical Devices Regulation (MDR) catalogue and be treated separately:
1. Harmonization and improvement of the designation and surveillance of notified bodies,
2. Harmonization and improvement of surveillance of manufacturers and market surveillance conducted by notified bodies and competent authorities,
3. Centralization of the registration of manufacturers and of vigilance reporting via Eudamed.
The PIP scandal has led to a great uncertainty of the public and of patients concerned. The event triggered an intensive discussion on how the present system may be improved in order to prevent the recurrence of cases similar to the PIP scandal or to reveal such cases much earlier." The medical device industry is interested in having a working healthcare market enabling us to ensure patients to benefit from a high quality standard in healthcare procurement. Our member companies wish to re-establish confidence in our sector and to strengthen it. They also wish to keep the EU healthcare sector competitive", states BVMed CEO Schmitt.
BVMed agrees with the European Commission that the present EU legal framework all in all has proven to be effective. Nevertheless weak spots of the system have been identified in the designation and surveillance of notified bodies as well as surveillance of manufacturers and the market. Even though the Commission proposal for a new European MDR gives good examples how these weak spots of the system may be improved, the final implementation of these amendments may take some more years. For the sector and the public this means an unnecessary loss of time and possible damage of the reputation of the EU healthcare sector. BVMed is therefore asking to take immediate action.