May 11, 2023
European Commission Requirement
The European Commission (EC) had been tasked with issuing guidance on the summary of the clinical investigation report (Article 77(6)). Many of us were reminded of this when said guidance was released (2023/C 163/06) May 8th.
Manufacturer’s requirements for clinical investigations
It is imperative that any manufacturer who has commenced a clinical investigation or is about to commence a clinical investigation is compliant with the requirements in the European Medical Devices Regulation (MDR) 2017/745, Declaration of Helsinki, and EN ISO 14155:2020.
Article 77 informs manufacturers that the clinical investigation report (and summary) is required irrespective of the outcome of the clinical investigation (Article 77(5)). The outcomes dictate the deadlines: if at the end of the clinical investigation, within one year, or if an early termination or temporary halt of the clinical investigation, within three months.
The contents of the clinical investigation report are delineated in Annex XV Clinical investigations, Chapter III Other obligations of the sponsor, Section 7.
EC guidance on summary clinical investigation report
The EC guidance is on the content and structure of the summary clinical investigation report. The EC provides the expected sections and includes guidance about the requested information on the extent of the information in each of the sections. In addition, there are references for each of the requested elements.
2.1 Cover Page
2.2 Content and structure of the summary of the clinical investigation report
Title of the clinical investigation - summary information
Purpose of the clinical investigation
Description of the investigational device, clinical investigation, and methods used
Results of the investigation
Conclusion of the clinical investigation
It is expected that the intended user of the device easily understands the report.
EC guidance references
In addition to the MDR, the EC references MDCG guidance documents and EN ISO 14155. Aspects of the guidance are adapted from EN ISO 14155:2020 Annexes D.7 and D.8, Results and Discussion and overall conclusion, respectively, from Annex D Clinical Investigation Report.
Consult this if you're compiling your summary clinical investigation report. There is a fair amount of guidance available.
And, be reminded that the EC implores that the summary clinical investigation report be succinct to "avoid simply copying bodies of text", uses appropriate language relevant to the intended user of the device, and omits "promotional content".
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