EU Commission announces delay to Medical Devices Regulation (MDR)
The new EU Medical Device Regulation (MDR) 2017/745, was due to replace the two existing directives, the Medical Devices Directive (MDD) 93/42/EEC and the Active Implantable Medical Devices Directive (AIMDD) 90/385 EEC on the 25th May 2020.
However with patient health and safety as a guiding principle, the Commission adopted a proposal on 3 April 2020 to postpone the application date of the Medical Devices Regulation (MDR) for one year.
Their goal is to have the Parliament and Council adopt the proposal by the end of May. This postponement will take the pressure off national authorities, notified bodies, manufacturers and other actors so they can focus fully on urgent priorities related to the coronavirus crisis.
The new regulations contain a series of extremely important improvements to modernise the current system. Among them are:
• 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