EU Finalizes New Medical Device RegulationA Q1 Productions 2017 White Paper
CHAPTER TWO: SUPPLY CHAIN TRACEABILITY
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:
Surveillance and Vigilance
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.