The overhaul (2012-2017) of the European legislative framework for medical devices was a missed opportunity to improve patient safety, notably by failing to require that high-risk medical devices undergo clinical evaluation before they can be placed on the market.

The "implant files" scandal revealed by journalists in 2018 once again highlighted the limitations of the current European system for regulating high-risk medical devices.

The shortcomings of regulatory authorities
Everything seems to indicate that for certain regulatory authorities, in France and in Europe, medical devices are just consumer goods like any other.

Under current rules, there is no need to obtain Marketing Authorisation (MA) or to demonstrate a positive harm-benefit balance in clinical use in order to obtain the required “CE” (European conformity) marking: the device has only to meet certain technical specifications. And rather than assigning responsibility for the regulation of this market to health authorities, the role of overseeing medical device manufacturers is outsourced to various “notified bodies".

Strengthening the entire legislative framework
The entire legislative framework needs strengthening. High-risk medical devices, in particular implantable devices, should only be granted a marketing authorisation once they have been demonstrated to represent a genuine therapeutic or diagnostic advance over existing alternatives, and to be safe.

©Prescrire December 2018