Module 19 2021

24/05/2021

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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Format of technical documentation

The following slides show the main headings of IVDR Annexes II and III. Comments are also provided in a few places in purple to highlight changes from the IVDD.

The Organisation for Professionals in Regulatory Affairs

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