Workshop on the Revision of EU Medical Devices Directive
The participants including 5 company representatives and 5 patients’ representatives shared their view on topics they defined as crucial within this revision process: the involvement of patients in the Regulation, re-use of single use devices, requirements for clinical evidence, provisions on transparency towards the public and information to patients, and the phasing out of hazardous substance in medical devices.
Participants also debated over the scrutiny mechanism and pre-market approval proposals for the authorisation of high risks medical devices that have been at the heart of the discussion in the European Parliament.
The discussion led to a better understanding of the respective positions of both parties, and helped define areas where we can continue and deepen the dialogue, and areas where clarifications are needed. Participants also discussed actions patients and industry could take in order to provide useful feedback to the Council that is currently discussing the Regulation.