Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

• A Notified Body must seek the scientific opinion of a relevant medicines regulator (EMA or medicines national competent authority) ‘with regard to the suitability of the device in relation to the medicinal product concerned’ • 60 day (+60 day) procedure • Technical documentation/instructions for use • Risk management system/post-market surveillance system • annual periodic safety update report • update clinical evidence throughout product lifecycle (post market performance follow-up) • serious incidents reported to medicines regulator • Public summary document IVDR: summary of CDx requirements (2)

The Organisation for Professionals in Regulatory Affairs

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Technical documentation/Instructions for use

• Intended purpose • ‘For the quantitative measurement of rhubarb in human serum on the SL+ instrument’ • ‘For use as a companion diagnostic in [relevant target population] to identify those likely to benefit from treatment with rhubarbimab’ • Include International Non-proprietary Name (INN) of the associated medicinal product(s) for which it is a companion test

Direct link between CDx and corresponding drug(s)

The Organisation for Professionals in Regulatory Affairs

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