Medical device manufacturers face challenges preparing for ‘stringent’ new EU Regulation
The countdown is on for medical device manufacturers to prepare for the EU Regulation on Medical Devices (MDR), which will fully apply in member states from May this year.
But in a recently published paper, trade association MedTech Europe raised concerns that the new regulatory system is not ready to support the transition of technology from the old regime.
The new EU MDR came into force on May 5, 2017, replacing two existing directives, and applies after a transitional period of three years, which falls on May 26, 2020.
Under the MDR, manufacturers have clearer obligations to monitor the quality, performance and safety of devices.
Also, existing devices which have been CE marked under the current EU Medical Device Directive (MDD) must be recertified to abide by the new MDR.
MedTech Europe says that manufacturers may not be able to keep existing devices on the market, because of challenges such as a lack of notified body (NB) capacity, lack of EU guidance on certain aspects of the regulation, and lack of expert panels.