The EU Medical Device Regulation (MDR – (EU)2017/745) will take effect on 26 May 2021 after being postponed for one year as a result of the COVID-19 pandemic. From this date, medical device manufacturers must meet a new set of standards before they can obtain the CE Mark and sell their products throughout the EU.
The implementation of the MDR presents a number of challenges for organisations. In particular, the regulations will shift focus from product approval to the full product lifecycle, demanding intensified clinical evaluation upfront. The MDR is also likely to substantially increase costs for organisations, particularly where devices that are already in use must meet new regulations and obtain recertification. Greater post-market scrutiny will also increase with a focus on product performance, safety and risk profiling, and swift incident reporting to achieve better patient outcomes.
It is important organisations understand the MDR and act early to develop a comprehensive clinical strategy. Doing so will not only enhance market positioning and competitive advantage but ensure the transition process is as smooth as possible. With extensive experience in medical device consulting Empirical Clinical Solutions can prepare and implement your pre-market and post-market clinical development strategy, helping you successfully achieve regulatory approval and market access under the new MDR.
Empirical Clinical Solutions also offers comprehensive training programs to help get your team MDR ready. Given the new regulations are specific to medical devices, training is particularly important for people from other scientific backgrounds to ensure they understand how to meet the needs of regulators. Training can be delivered online or at your site and tailored to the specific needs of your organisation.