Module 19 2021

24/05/2021

● 1. DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND ACCESSORIES 1.1. Device description and specification Comment: – The Basic UDI-DI is required – The intended purpose of the device is outlined in some detail – 1.2. Reference to previous and similar generations of the device Comment: – An overview is required of similar devices available on the Union or international markets, where such devices exist. IVDR Annex II, main headings

The Organisation for Professionals in Regulatory Affairs

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IVDR Annex II, main headings

● 2. INFORMATION TO BE SUPPLIED BY THE MANUFACTURER Comment: – Requires a complete set of labels and IFU’s in the languages of all Member States where the device is sold ● 3. DESIGN AND MANUFACTURING INFORMATION – 3.1. Design information Comment: – Software requires algorithms – devices for self-testing or near-patient testing require a description of design aspects that make them suitable for those purposes

The Organisation for Professionals in Regulatory Affairs

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