Module 19 2021

24/05/2021

Tecs

Technical Documentation Documentation Module 19, Regulation of In Vitro Diagnostic Medical Devices Lecture 5 Ben Jacoby nd June 2021

Ben Jacoby, Cambridge RA Ltd.

ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

The Organisation for Professionals in Regulatory Affairs

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Scope

The focus is on European legislation:

 Regulation (EU) 2017/746 on in vitro diagnostic medical devices  IVD Regulation, abbreviated ‘IVDR’

 Directive 98/79/EC on in vitro diagnostic medical devices  IVD Directive, abbreviated ‘IVDD’ More emphasis on IVDR than IVDD

The Organisation for Professionals in Regulatory Affairs

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