Changes in Europe's Medical Device Regulations: Consequences for Manufacturers
Peter Diesing, Ph.D.
Head of Certification Medical Device, Eurofins Medical Device Testing
A European Law (MDR) revised the Medical Device Regulation in Europe completely in 2017. The MDR replaces the Medical Device Directive 93/42/EEC and creates many new requirements for manufacturers, notified bodies and competent authorities. This will influence the work of all medical device manufacturers bringing the product to the European market, whether they produce the devices in the European Union or outside the community. This presentation will give a short overview of the new regulation with the focus on the new requirements for manufacturers coming from outside the European community.
Dr. Peter Diesing is the Head of Medical Device Certification for Eurofins Product Service GmbH where he has built up the notified body and testing lab since 2013. During his career, he has worked as a Marketing Manager in the field of Hemodynamic with B. Braun Melsungen AG and a General Manager and Head of Certification Body at Berlin Cert GmbH. Dr. Diesing studied Biomedical Engineering at the Technical University of Berlin, where he also finalized his scientific work.