16/17 November 2021
In the aftermath of the PIP scandal, the EU has been planning for a long time a tightening of the rules for medical devices. In future, two regulations for medical devices and in vitro diagnostics (IVDs) will be created on the basis of the 3 existing guidelines for medical devices (plus a supplement). How does the agreement of the EU look like?
The two regulation drafts have been aligned and should increase the safety of medical devices. They include more comprehensive requirements concerning placing devices on the market (particularly for so-called high risk devices) and extensive requirements with regard to market surveillance. Also the rules for notified bodies will be strengthened - i.e. the surveillance of them by the authorities. Besides, according to the new regulations notified bodies will have to perform unannounced inspections at manufacturers.
Moreover, the protection of patients involved in clinical studies should be enhanced and new products without medical benefits (like coloured contact lenses) should be covered by the medical devices legislation in future. In addition to a central database for medical devices to be created, a unique identification number will ensure traceability of medical devices throughout the whole supply chain.
After their formal adoption, the regulations will apply after a 3-year transition period (for medical devices) and after 5 years (for IVDs)
You will get an overview of the coming changes in the EU press release "Medical devices: deal reached on new EU".