The new In Vitro Diagnostic Device Regulation (IVDR) has entered into force as of 26 May 2017 and will serve as the basis for access to the European market. To receive certification to the IVDR, IVD device manufacturers must have a compliant Quality Management System (QMS) in place.
For manufacturers of IVD devices selling into Europe, join this session to hear Dr. Stefan Burde provide guidance about the key changes for meeting regulatory requirements and maintaining a QMS under the IVDR, and to support your preparation for an efficient transition or initial certification.
