How the MDR has changed the roles and responsibilities of “economic operators”

Under the Medical Devices Regulation economic operators – that is manufacturers, the authorised representative, importers and distributors – all face new roles and obligations. While some of these responsibilities existed under the Medical Devices Directive, workload will be impacted. From requirements around Eudamed, to having a person responsible for regulatory compliance, to ensuring certain obligations are properly followed through to complaint management, the roles of all economic operators are affected and require careful consideration by companies with devices in the European market.

Clare Huntington is Director and Head of Medical Devices / IVD UK at PharmaLex

Clare leads the UK and EU teams and consults on industry-wide issues including drug/device combination products, clinical trials, device classification and regulatory submissions, and post-market requirements. Clare has worked in a variety of roles in the medical device space during her career, including the MHRA, a Clinical Research Organisation, as an EU Authorised Representative, as well as industry, leading the regulatory affairs activities. This has given her a broad understanding of the EU regulatory landscape which enables her to provide comprehensive advice to clients that covers the full product life-cycle.