Focusing on the Details: MDR PART I

06 December 2018

Released in May 2017 with a commitment period of three years, the European Medical Device Regulation (EU MDR) represents a significant change in the way medical devices are monitored in the European Union, and aims to create more transparency and accessibility in the €100 billion medical device market. There are more than 500,000 medical technologies registered and 95% of Europe’s 25,000 medical technology companies are small and medium-sized enterprises (SMEs).

Legacy devices, currently manufactured and marketed/CE marked under existing directives are expected to meet the new requirements set out in the MDR. And the MDR introduces new concepts, definitions, classification rules and procedural requirements for medical device software – specifically software products currently regulated as Class I medical devices in Europe. Many digital health technologies will now fall into the scope of the MDR.

But what does all of this mean? How do these changes impact the regulatory requirements for CE marking.

In PART I of a two-part MDR webinar series, guest presenter, Yvonne Middlefell, RAC, will discuss the differences between the Medical Device Directive (MDD) and the MDR and how the new regulations apply to clinical evaluations, and software/mobile applications.


A highly experienced regulatory professional with more than 29 years’ experience in Global Regulatory Affairs, Quality and R&D, Yvonne Middlefell, RAC, FRAPS, is currently the Executive Director of Stellar Regulatory Consulting, LTD.  She has in-depth knowledge across a broad range of disciplines, including medical devices, in-vitro diagnostics, biologics, pharmaceuticals and OTC. Yvonne has written and submitted more than 30 510(k) submissions, PMAs, IDEs and BLAs and established RA functions for multinational organizations. She holds a 2:1 Hons degree in Science, Technology and Management from the Open University, United Kingdom.