Module 19: Regulation of In Vitro Diagnostic Medical Devices

28/03/2023

Lecture 5 Technical Documentation What is it? How should it be compiled? How to write a DoC

Wednesday 19 th April 2023

Ben Jacoby, Cambridge RA Ltd. bjacoby@cambridge-ra.com

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

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Scope

Directive 98/79/EC on in vitro diagnostic medical devices

Regulation (EU) 2017/746 on in vitro diagnostic medical devices

IVD Regulation, abbreviated ‘IVDR’

IVD Directive, abbreviated ‘IVDD’

The focus is on European legislation:

More emphasis on IVDR than IVDD

details omitted for For general awareness only, brevity

The Organisation for Professionals in Regulatory Affairs

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