EU Finalizes New Medical Device Regulation

A Q1 Productions 2017 White Paper


The Regulation incorporates a wide variety of new regulatory processes and standards, which will improve the traceability of medical devices, allowing for greater visibility throughout the supply chain, from manufacturer to end-user. Creating greater complexity within an already dynamic and evolving market, the new Regulations, while meeting the mandate of greater traceability and transparency, will also alter the relationship and distribution of products across the continent, placing a greater legal and oversight burden on importers and distributors.

Within the MDR, authorities have integrated enhanced levels of responsibility and legal liability throughout the supply chain for products, placing an increased burden on not only manufacturers, but also on product importers and distributors. Safety reporting and the collection and reporting of complaints or product faults have also become the responsibility of importers and distributors.

To read more about the importer duties and distributor responsibilities, download our whitepaper.

The six topic areas we will cover include changes to the following:

Notified Body
Quality Management
Supply Chain
Surveillance and Vigilance
Technical Files

This paper looks to provide a summarized overview of the provisions within the regulation which will impact medical device manufacturers—from CE marking and technical document management to quality management systems.