Location

Productivity and Quality Institute - Alexandria

Objectives

• This course is focused on understanding the requirements of the Medical Device Directives / Regulations, and the requirements of CE Marking and ISO Certification on commercializing products. The course covers all relevant topics in brief associated with the Directives and Guidance Documents, the reasons behind their introduction and a review of methods for effective implementation.

Outcomes

Upon completion of this course attendees will have a thorough knowledge of the requirements for developing and marketing Medical Devices. The Directives are complex and the requirements differ somewhat by Member State. The content of this course is designed to simplify the understanding of all requirements and to provide attendees with the latest information regarding interpretation and enforcement of these regulations.

Course Contents

• Changes in the structure and administration of the Regulation• An Overview of the legislation around medical devices• New Economic Operators affected by the Regulation• Key changes to the requirements • Scope of the MDR• Device classification• Conformity Assessment Procedures• Safety and Performance Requirements• Requirements for technical documentation• Unique Device Identifiers (UDI)• Declaration of Conformity• Post-Market Surveillance and vigilance • Transition arrangements as stipulated within the Regulation