Donawa: Sponsors should focus on the specific advice that addresses European regulatory expectations which are more specific than the good clinical practice (GCP) described in ISO 14155:2020.

Unfortunately, to identify this type of advice, it is necessary to conduct a side-by-side comparison between the text of the guidance and Annex A (normative CIP) of ISO 14155:2020. This is because the new guidance consists of advice based on experience from competent authorities and text that is slightly modified, but in some cases, identical to that of the standard.

For example, in the new guidance, Section 3.3, Benefits and risks of the investigational device, clinical procedures and clinical investigation, includes very detailed information on benefits and risks and the benefit-risk ratio based on MDR requirements and how they might be interpreted in Europe by competent authorities. In contrast, Clause A.4, Benefits and risks of the investigational device, clinical procedure, and clinical investigation, of ISO 14155:2020, is more concise and lists only the fundamental types of information that should be provided in the CIP, consistent with its international nature.

Yet, in the guidance, Section 3.7, Statistical design and analysis, the text is largely the same as in the standard.

Whenever the guidance includes text that is similar or identical to the standard, sponsors should use the standard.

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