Location

Productivity and Quality Institute - Alexandria

Objectives

• Learn about the key requirements of the new In Vitro Diagnostic Regulation (IVDR EU 2017/746), published in Spring 2017 with a five-year transition period. The Regulation will affect all In Vitro Diagnostic device manufacturers, importers, distributors and Representatives.

Outcomes

• Identify the key requirements of the In Vitro Diagnostic Regulation• Interpret and communicate the key requirements and expectations of the IVDR to your organization.• Identify the next steps in planning of product realization and commercialization in conformity with the IVDR.

Course Contents

• Identify devices that are within scope of the Regulation• Understand the roles and responsibilities of the different Economic Operators identified by the Regulation• Identify other key players and their obligations under the Regulation• Identify key requirements concerning the following steps for conformity assessment:• Determine the risk class of IVD• Select conformity assessment procedure• Identify applicable General Safety and Performance Requirements (GSPRs)• Recognise key elements of Technical Documentation• Appreciate the importance of product claims, labelling, Unique Device Identification (UDI) and EUDAMED (The European Database on Medical Devices)• Identify requirements of clinical evidence• Post-Market Surveillance and updates