The proposed EU medical device regulation is designed to lead to better clinical evidence and improved patient safety. Measures such as the scrutiny procedure, improved postmarket surveillance and vigilance, and more devices being classified as high risk, should prevent disasters such as with the PIP breast implants from happening. Next week the MDR proposal will be discussed by the ENVI Committee, and some people anticipate heavy debate and others, such as Eric Vollebregt, expect it to become a “disappointing dud”. EUCOMED recently criticized the proposal as in its current form the scrutiny procedure would not contribute to patient safety but just hamper the innovative power in Europe, and they suggested seven measures for improvement.
Clinical research perspective
Looking at the MDR proposal from clinical research perspective, there are two elements that I find important to keep an eye on: One is that it will result in increasing demands for clinical trials because more and better clinical evidence is needed to substantiate patient safety. The second element is that the proposal includes the processes for clinical investigations and postmarket clinical follow-up, as well as the requirements for pre- and postmarket safety reporting. As the proposal concerns a regulation replacing the existing directives (AIMDD and MDD), this can be potentially advantageous when running pan European trials: dealing with one general European regulation as opposed to dealing with different country regulations on top of ISO 14155 and the different Ethics Committees requirements will be much clearer.
Given the current debate, the implementation of the MDR in any format is likely to take several years: In the mean time we will need to deal with the current tangle of standards, directives, and regional regulations in Europe that are guiding clinical research practises including adverse event reporting. The latter topic I will be speaking on at the Q1 webinar in March.