On May 25th, 2017, a new era began. The date marks the beginning of the Medical Device Regulation, the MDR in short. It provides a new framework for the certification of medical devices in Europe and is supposed to increase the transparency of the approval and application of medical devices, as well as to improve patient safety.
New guidelines are challenging for all parties involved
Patient safety is always of utmost priority; everybody agrees on this goal. However, with the new EU legal framework, we, in the medical technology industry, are faced with existential challenges: New clinical requirements as well as comprehensive documentation and reporting obligations will result in an increased bureaucracy. This also threatens to overstrain the notified bodies, which will be intensified through the decline in the total number of bodies and also through the loss of the British notified bodies in the course of Brexit. A lack of implementation regulations due to delayed detail regulations of the MDR significantly reduce the three-year transitional period for companies’ implementation.
In my opinion, this represents a very critical situation for the medium-sized MedTech sector. But it is not just the medical technology companies that are affected by the current developments: Patients’ immediate access to modern procedures, devices, and examination methods will be made more difficult, and innovation will be delayed.
Pragmatic solutions for a stronger culture of progress
A development that I see as very critical, considering that our goal is to bring medical progress to patients more quickly. Meaning there is a stronger culture of progress in patient care through new technical solutions, a positive atmosphere for medical and technical progress, and a quicker transfer of research findings.
To expedite this development and to protect and improve the health of people all around the world, we need pragmatic solutions for the implementation of the MDR. This includes planning security as well as clear guidelines with regard to the implementation and standards of clinical trials. In addition, politicians should advocate an extension of the transitional regulations in order to support the stated goals. In this context, it is not helpful to link the evaluation of healthcare technologies (Health Technology Assessment – HTA) to the MDR, as currently suggested by the EU Commission. I believe that it is only through a culture of progress that is oriented towards patients’ needs that we can continue to successfully shape healthcare in the future.