Europe – May 2019 Regulatory Roundup: Europe on the verge of MDR

With the European Medical Devices Regulation (MDR) coming into force in less than one year, plus related challenges such as Brexit, Notified Body capacity and Eudamed database implementation, manufacturers of CE-Marked devices have a lot to track in order to maintain European market compliance.

To help companies familiarize themselves with the latest European market and regulatory developments, we’ve summarized Emergo by UL blog coverage over the past several months for your review.

MDR clinical requirements

One of the MDR’s most significant impacts for medical device manufacturers will be on their clinical investigation and data obligations:

  • MDR establishes new rules for clinical study investigator and site selection processes
  • Manufacturers should make early preparations to comply with MDR post-market clinical follow-up (PMCF) data requirements
  • How MDR will tie PMCF data more closely to post-market surveillance and clinical evaluation report (CER) requirements…