MDR and Combination Products

3/9/2020 11:35 - 12:10

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.

Please note that this will be a remote presentation

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