Manufacturers are beginning to take action with respect to the European Medical Device Regulation (MDR), including the Regulation’s new approach to post-market surveillance, or PMS.
In the past half year (January through June 2018), Emergo has observed data to support two global trends: Initiatives to enhance device tracking and traceability, and simplification of the regulatory process for the lowest-risk medical devices.
This is our second installment of global medical device regulatory updates and observations related to global trends. In the past few months (July through November 2018), we have observed data to support several global trends. We could wax philosophical on what constitutes a trend, though suffice it to say, our professional judgement has identified the following themes: