Requirements of the In Vitro Diagnostic Regulation

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.

To CE mark an IVD in Europe it will soon be mandatory to conform to this Regulation. The Regulation will affect all In Vitro Diagnostic device manufacturers, importers, distributors, and EU Representatives.

Prerequisites

There are no formal prerequisites for this course.

Pedagogical objectives

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

Skills to be acquired

By the end of the course, delegates will be able to:

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

Targeted audience

Manufacturers of In Vitro Diagnostic devices, in particular those who have not yet placed an IVD on the market in the EU, especially: Regulatory Affairs, Design and Development, Clinical Affairs Specialists, Quality Management, Quality Assurance personnel, and other Economic Operators including manufacturers, importers, distributors and authorized representatives who are new to, or have little familiarity with, the EU IVD market.

Pedagogical, technical and framing means

Course materials including:

Introduction to the training, detailed program and security assignments
Course presentation, theory and activities/ role plays
Answers to the activities
Videos
Additional documents, distributed during the sessions, to use for the
activities
Attendance sheet to be signed