Module 19: Regulation of In Vitro Diagnostic Medical Devices

28/03/2023

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How to write technical documentation

The Organisation for Professionals in Regulatory Affairs

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IVDR Annex II, main headings

● 1. DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND ACCESSORIES 1.1. Device description and specification - ‘The intended user and use environment should be clearly described within the technical documentation. - The intended use, user, target population and clinical condition / physiological state must be supported by the results of the clinical performance evaluation. - ’

The Organisation for Professionals in Regulatory Affairs

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