From today, the MDR, the new European Regulation on Medical Devices, that came into force in May 2017, has full applicability. After a one-year postponement due to Covid, it wonders how the various actors involved in the fulfilment of the new duties required by EU Regulation 2017/745 are.

The MDR, which replaces the old Directive, implements several new features. Here they are.

rom Post Marketing Surveillance to the GDPR, here are the government decrees for the implementation of the MDR.

With the entry into force of the MDR there are several areas that have been revised as they are treated more roughly in the old Directive, among these there are also the information supplied with the device: in order to present the correct use of your device , each manufacturer is in fact required to affix on labels, packaging and instructions for use, all the information necessary for its use, such as the risks and benefits, operating methods, CE mark, etc. Let's see the updates.

Here is the list of all significant and non-significant changes and dos and don'ts to take advantage of the transition period of the MDR.