MDR and Combination Products

Date: March 9, 2020
Time: 11:35 AM - 12:10 PM

Global Drug Delivery and Formulation Summit
Maritim proArte Hotel Berlin
Friedrichstrasse 151,
10117 Berlin,

March 09, 2020

The European Medical Device Regulations (MDR) were fully implemented on May 26 2020, thus completing a three year transition period from the previous Medical Device Directive (MDD). Although manufacturers have had three years to prepare, the requirements in MDR are significantly more demanding than with MDD. One key change in MDR, when compared to its predecessor MDD is the enhanced focus on usability. In particular, notified bodies have an enhanced role in ensuring that manufacturers of combination products are providing adequate evidence that the device part of combination products can be used safely and effectively for its intended purpose. In this session, we will review the role of notified bodies in combination product approvals, and provide insight into the usability requirements in MDR for the device part of combination products.



  • Richard Featherstone
    Research Director, Human Factors Research and Design, Emergo by UL

    The Cambridge team is headed up by Richard Featherstone, an experienced human factors and usability practitioner and the founder of Medical Device Usability Ltd. Richard has thirty years’ of experience in the pharmaceutical, medical device and human factors industries. Richard advises some of the world’s largest medical device and pharmaceutical companies on their HF strategies, and works globally on formative and summative testing programs.