Proposal for a regulation to simplify rules on medical and in vitro diagnostic devices

This proposal for a regulation is a response to requests from the European Parliament, several Member States and numerous stakeholders for a simplification of the regulatory framework for medical devices and for measures to ensure the availability of devices. A new regulation is needed to remedy the problems that have been identified, which otherwise would have a considerable impact on the medical devices market and, consequently, on the quality of healthcare provided to patients in the EU. ...