New Guidance: Summary Clinical Investigation Reports

The European Commission (EC) has recently issued vital guidance (2023/C 163/06, dated May 8th) concerning the summary of clinical investigation reports, as mandated by Article 77(6). Manufacturers embarking on or planning clinical investigations must strictly adhere to the European Medical Devices Regulation (MDR) 2017/745, Declaration of Helsinki, and EN ISO 14155:2020.

According to Article 77, clinical investigation reports, including summaries, are obligatory regardless of the investigation’s outcome (Article 77(5)). Deadlines are contingent upon investigation results: within one year post-investigation completion, or within three months for early termination or temporary halts.

The specific content requirements for clinical investigation reports are meticulously outlined in Annex XV Clinical Investigations, Chapter III Other obligations of the sponsor, Section 7.

The Commission’s guidance delineates the expected structure and content for the summary clinical investigation report:

  1. Cover Page
  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 crucial that the report is comprehensible to the intended user of the device. The EC’s references include MDR, MDCG guidance documents, and EN ISO 14155. Notably, the guidance incorporates elements from EN ISO 14155:2020 Annexes D.7 and D.8, specifically focusing on Results and Discussion, and overall conclusion, as found in Annex D Clinical Investigation Report.

Manufacturers are strongly advised to consult this guidance thoroughly while preparing their summary clinical investigation reports. The European Commission emphasizes the importance of being concise, refraining from verbatim text replication, using language appropriate for the device’s user, and excluding any promotional content.