Module 19: Regulation of In Vitro Diagnostic Medical Devices

28/03/2023

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The IVDD has no fixed format for technical documentation. By contrast IVDR Annexes II and III are quite prescriptive. This should drive more consistency around the content of technical documentation for example both within and between different manufacturers. Format of technical documentation

The Organisation for Professionals in Regulatory Affairs

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Some notified bodies have their own guidance for IVDR, e.g.:

bit.ly/3sHnXip

The Organisation for Professionals in Regulatory Affairs

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