The Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, repeals Directive 90/385/EEC and Directive 93/42/EEC.
The MDR regulates:
Medical devices for human use and related accessories.
Devices not placed on the market but used in a context of a commercial activity to provide a diagnostic or therapeutic service through the information services of the company or with other means of communication.
Products that are not intended for medical use.
From 27/05/2024 only medical devices compliant with the MDR with a valid EU certificate of conformity issued pursuant to the MDR can be placed on the market.
The devices are divided into 4 classes of risk: I, IIA, IIB and III depending on the intended use and the risks it entails. The classification is carried out by the manufacturer according to the criteria indicated in the regulation. Before placing a device on the market or in service, the manufacturer shall carry out a conformity assessment of the device in accordance with the applicable conformity assessment procedures.