MDR Regulation Revision Background

MDR Regulation Revision Background

Some concerned voices say that the new regulations place unrealistic demands on the industry including the cost of certifications by a notified body.  The limitation of resources to fulfill the new regulatory demands could lead to significant delays for product approval in certain areas and subsequently the healthcare industry may lack the availability of important products.  In particular the short timeline for the MDR transition is considered very critical.

The majority, nevertheless, believes that this Regulation is a big progress towards increasing patients’ safety and will allow rebuilding trust between the public sector and the medical industry, by ensuring a greater surveillance as well as a balance between innovation and economic interests.

Here is a video from the European Parliament on the subject:
https://www.europarltv.europa.eu/en/programme/economy/medical-devices-better-regulation-for-europe