The second edition PD CEN ISO/TR 24971:2020, Medical devices - Guidance on the application of ISO 14971, provides extensive guidance on all clauses of BS EN ISO 14971:2019. The report follows the same structure and clause numbering as the standard. The requirements in the standard and the guidance in the report are intended to be applied together. Several annexes of BS EN ISO 14971:2007 have been moved to the report, merged with the guidance of the first edition PD ISO/TR 24971:2013, restructured, updated and supplemented with additional guidance.
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