Module 19: Regulation of In Vitro Diagnostic Medical Devices

28/03/2023

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Team NB Position Paper

Information to be supplied by the manufacturer – a collaborative notified body approach. • The following slides include selected text from the Position Paper within ‘quotation marks’. Some text is highlighted in yellow to show particular emphasis. https://www.team-nb.org/team-nb-pp-best-practice-guidance-for-the-submission-of technical-documentation-under-annex-ii-and-iii-of-in-vitro-diagnostic-medical-devices regulation/

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 Basic UDI-DI must be consistent throughout the technical documentation - For devices grouped under one basic UDI-DI number please describe the differences to demonstrate how these falls under the same group.’

The Organisation for Professionals in Regulatory Affairs

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