EU: New guidance document for the "clinical evaluation assessment report template"

The MDCG has issued a guidance document with a template for the evaluation report issued by notified bodies regarding the clinical evaluation of manufacturers (MDCG 2020-13).

Although the template is primarily intended for notified bodies, it also details the minimum content specified for the clinical evaluation tests; manufacturers should take into account this information when performing clinical evaluations and creating corresponding plans and reports.

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