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.
Meanwhile, Polymer solutions manufacturer Trelleborg said the firm has had to carry out “extensive testing” to ensure its materials, which are used in some medical devices, comply with “the stringent requirements” of the new regulation.
Andreas Schmiedel, technical manager at Trelleborg’s healthcare and medical operation in Europe, said: “Meeting it [MDR] is challenging, as the regulation means complying with other standards that are applicable to the application, such as ISO 10993.”
WHY IT MATTERS
The regulation applies to all medical devices for human beings, including digital health. It aims to improve patient safety by introducing more robust procedures for conformity assessment and post-market surveillance.
MDR also specifies requirements for the data collection of clinical investigations on medical devices, which have been aligned with the requirements for clinical trials on medicinal products.
THE LARGER CONTEXT
A study last year found that just 27% of 230 device makers surveyed expect to be in compliance with the MDR by May.
Of those surveyed, 46% said they will leverage the MDR’s transitional provisions to be able to sell their products in the EU until 2024, while working on their compliance programmes.
ON THE RECORD
MedTech Europe director for regulations and industrial policy Oliver Bisazza said: “Generally, we see increasingly wider recognition of the seriousness and urgency of the issue. The MDR was included in the agenda of the 9 December meeting of employment, social policy and health ministers at the Council of the EU (EPSCO).
“National authorities are aware of the issue and we were reassured by the large number of ministers with device expertise who supported a call on the European Commission’s Medical Device Coordination Group (MDCG) to do a readiness check on the MDR.”