The new legislation provides for:
- random inspections of producers’ facilities after devices have been placed on the market,
- stricter controls on notified bodies, which will have to employ medically skilled people, an additional safety checking procedure for high-risk devices, such as implants or HIV tests. Not only a notified body but also a special committee of experts will check that all requirements are met,
- an “implant card” for patients, enabling patients and doctors to track which product has been implanted,
- clinical evidence of medical device safety to be provided by manufacturers (as for medicines), especially in the case of higher risk classes.