On 26th May 2020 the 2017/745 EU regulation on medical devices will entry into force. It was discussed at 59th AFI Symposium, the Italian event dedicated to pharmaceutical sector, during the workshop intitled “The new regulatory frontiers of medical devices: how to approach them in an European and international context”. Here is what emerged.
One of the aims of the new rules is to guarantee a higher safety on medical devices. A better clinical evaluation is required, which is currently lacking: the producers will have to fill in the gaps and to improve the processes of clinical data collection, especially for the new products, for which it will no longer be possible to use the equivalence approach, but the appropriate clinical investigation must be carried out.
Post-marketing surveillance will also need to be optimized: an active and systematic system that is able to collect and analyze data on the quality, performance and safety of the device will be required.
In this regard, Eudamed, the new European web-database for market surveillance of medical devices and in vitro diagnostic medical devices, will play a key role. This will act as a central archive, a system for the exchange of information between the National Competent Authorities and the European Commission and as a support of uniform application of the new rules.
Data that have to be reported concern:
- the register of manufacturers, representantives and authorized devices
- the released, modified, integrated, suspended, withdrawn or refused certificates
- the procedures of vigilance on accidents or almost accidents that occur during the use of the medical devices.
The clinical evaluation must become integral part of the internal procedures and it will be a crucial step in the process of marketing the medical devices in Europe, since they have to comply with safety standards.