The EU Medical Devices Regulation (MDR 2017/745)

On April 5, 2017, the EU adopted the new Medical Device Regulation, replacing the two existing directives, the Medical Devices Directive and the Active Implantable Medical Devices Directive.

The new Medical Device Regulation will enter into force after a three-year transition period ending on May 25, 2020. This means that the market access framework for all member countries of the European single market (28 EU member states including the UK, the members of the EEA – Iceland, Lichtenstein and Norway, and through bilateral treaties Switzerland) will change significantly.

Key changes

The aim of the new Medical Device Regulation is to address some inherent weaknesses in the old directives as well as the swift evolution of science and technology in the field of medical devices. To do so, it introduces several key improvements, among them:

• stricter ex-ante control for high-risk devices via a new pre-market scrutiny mechanism with the involvement of a pool of experts at EU level
• the reinforcement of the criteria for designation and processes for oversight of Notified bodies
• the inclusion of certain aesthetic devices which present the same characteristics and risk profile as analogous medical devices under the scope of these Regulations
• improved transparency through the establishment of a comprehensive EU database on medical devices and of a device traceability system based on Unique Device Identification
• the introduction of an “implant card” containing information about implanted medical devices for a patient
• the reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for authorisation of multi-centre clinical investigations
• the strengthening of post-market surveillance requirements for manufacturers
• improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance