EU Finalizes New Medical Device Regulation

New Medical Devices Regulation and IVD Regulation Now Published

After more than five years of debate, negotiation and consultation, the new European Medical Device Regulation was published in the Official Journal of the European Union on May 5, 2017, including formal implementation and compliance mandates. The new regulation, which replaces the Medical Device Directive 93/42/EEC, was driven largely by the need for greater scrutiny of medical technology and the need for the European Commission to ensure the ongoing safety and quality of medical products sold and utilized in the European Union. Industry manufacturers and related stakeholders are facing some of the most significant changes in decades, as the regulation has an expanded scope requiring all devices currently marketed in Europe to be transitioned into the new system.

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

Clinical
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.