Combination products, usability, and the EU MDR


The European Medicines Agency (EMA) has recently issued draft guidance on Drug Device Combinations (DDC) that calls for usability studies, to come into full effect in December 2020. The Medical Device Regulations (MDR) also tighten the usability requirements for manufacturers of drug device combination products (DDC).

The device component of a DDC now falls within the scope of notified body (NB) review. So pharmaceutical manufactures, and platform device developers, need to be aware of the requirements when planning their product development activities. Submissions to European regulators for a DDC now need to include usability data, and the device component will be reviewed by a NB.

In this webinar, we will review the usability requirements in the EMA guidance, describe how they align with MDR and highlight the key requirements for manufacturers.

PRESENTERS:

Ronald Boumans, Senior Consultant, Regulatory Affairs (Europe)

Richard Featherstone, Research Director, HFR&D (Europe)

This webinar was recorded on May 14, 2020.