How The MDR Has Changed The Roles And Responsibilities Of 'Economic Operators'

With the implementation of the Medical Devices Regulation, economic operators including manufacturers, authorized representatives, importers, and distributors encounter revised roles and obligations. Although some of these duties existed under the Medical Devices Directive, there will be a notable increase in workload. From compliance with Eudamed requirements to appointing a regulatory compliance officer and ensuring proper management of complaints, the responsibilities of all economic operators are significantly impacted, necessitating careful consideration by companies with devices in the European market.
Speaker Bio: Clare Huntington is Director and Head of Medical Devices / IVD UK at PharmaLex. She 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. Huntington 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.
Get unlimited access to:
Enter your credentials below to log in. Not yet a member of Clinical Leader? Subscribe today.