The year 2016 brings about the new, eagerly anticipated Medical Device Regulation (MDR). The revision needs to now be implemented by all EU member states in the coming years after there have been ongoing deliberations and negotiations since October 2012. We spoke with Professor Ernst Klar of the German Society of Surgery (DGCH), also a delegate of the AMWF (The Association of the Scientific Medical Societies in Germany) and asked how satisfied the medical societies are with the new Regulation.
Professor Klar, the new European Medical Device Regulation (MDR) has been in effect since earlier this year. Is the AMWF happy with the results?
Ernst Klar: Before I can answer this question, you first need to understand how this revision came to be. Several years ago, a scandal surrounding defective and poorly produced breast implants clearly showed the need for improvements in patient safety and benefit/risk assessments for medical devices. This was addressed by the European Parliament and the European Commission. The intention was to revise and tighten the then effective Medical Device Directive. The new Medical Device Regulation is therefore based on an existing Directive. Over the past years, we strived to ensure that the MDR is not impeding innovations and to prevent constraining regulations. We did not want to tip the scales so to speak. The MDR was now adopted in June of this year and includes basic tenets of several opinions delivered by the medical societies. We noted that many of the aspects we requested have been incorporated. Now it’s up to the individual countries to implement the MDR and adapt it to their settings. We believe this is a great advancement that protects patients but also allows for innovative changes. We are all in all relatively satisfied with the legislative text. ...
Read the whole interview with Prof. Ernst Klar here!