Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Introduction

 IVDR is the starting point to design a device but what other directives and regulations do we need to consider???

These may be based on :



● Safety

● Sustainability

● Security

A few are now referenced in the IVDR most reference IVDs in

them whether to scope in or out

The Organisation for Professionals in Regulatory Affairs

3

REACH – 1907/2006 Registration, Evaluation, Restriction and Authorisation of Chemicals

Regulation – published 18 December 2006

• Now referenced in IVDR Annex I, Chapter II

• Provides protection to human health and environment

• Applicable to substances manufactured in or imported into EU if quantity is >1 tonne/year

• Applicable to chemicals on their own, in mixtures or in an article if substance is released during normal use

The Organisation for Professionals in Regulatory Affairs

4