Task Force Regulatory Affairs and Medical Devices
Workshop on Medical Device Registries:
The BioMed Alliance organised a joint workshop on Medical Device Registries with the European Society of Cardiology (ESC) and the European Federation of National Associations of Orthopaedics and Traumatology (EFORT) on 17 June. The programme included speakers from the European Commission, member societies, a notified body, industry, the European Medicines Agency and experts who manage successful registries across Europe.
The all-day workshop provided an overview of different perspectives on registries and was attended by around 65 participants representing regulatory authorities, medical device companies, registries and medical societies. The presentations showed that there are some successful registries in Europe and that regulators and industry representatives see the added value of having access to high-quality registries. Nonetheless, regulatory and practical barriers remain and hinder the realisation of their full potential.
The following day, the second meeting of the taskforce on regulatory affairs and medical devices took place. Taskforce members discussed the workshop, ongoing participation in EU Commission working groups, the Medical Devices Regulation (MDR) and the future activities of the taskforce. Dr. Paul Piscoi – EC DG GROW, joined the meeting and provided key insights on the MDR implementation.
The European Commission has shared the announcement of its call for clinical experts to take part in expert panels on medical devices and in vitro diagnostic devices. It is to be expected that the call will be published later this year.
The new Medical Devices Regulation will regulate the development, authorization and post-market surveillance of medical devices. A new element under this regulation is the establishment of expert panels that will play a role in assessing high-risk medical devices and advising regulators.
It is essential that a broad variety in experts from different disciplines take part in these panels to ensure that the safety of medical devices on the European market is guaranteed. We encourage our members to timely identify potential candidates and prepare for the European Commission call for recruitment in advance.
The EU Medical Devices Regulation will apply in 2020 and proposes stricter control on medical devices. Therefore, the discussion on the role of registries in providing advice to regulators is very relevant.
by Eveline Sipido, Liaison Officer to the European Academy of Neurology. She is in charge of EAN’s relation with the European Union and sub-specialty societies. She also works on the regional teaching courses in sub-Saharan Africa.