European Commission guidelines for the optimal drafting of the summary of the clinical investigation report under the MDR
The European Commission recently published the “Commission Guidelines on the Content and Structure of the Summary of the Clinical Investigation Report” (2023/C 163/06). These guidelines provide guidance on how to prepare the summary of the clinical investigation report in accordance with Article 77 of the Medical Device Regulation (MDR). In this article, we will examine the report summary from the perspective of the MDR and highlight its key elements.
According to Article 77(5) of the MDR, the sponsor of the clinical investigation must submit, within one year of the conclusion of the investigation (or within three months in the case of earlier conclusion), a report on the clinical investigation to all member states in which the investigation was conducted. This report should follow the content specified in Annex XV, Chapter I, item 2.8 and Chapter III, item 7.
In general, the clinical investigation report should include the following:
- Investigation and device identification data and details of investigators for each investigation site;
- Summary of the investigation and clinical investigation plan;
- Critical appraisal of all data obtained during the clinical investigation, including any negative results;
- Summary of serious adverse events, defects and any corrective actions.
Since the clinical investigation report is a complex document, the MDR, in Article 77(5), requires that it be accompanied by a “Summary of the Clinical Investigation Report.” This summary must be written in language understandable to the intended user and transmitted along with the report through Eudamed’s electronic system, as stipulated in Article 73 of the MDR.
Other features of the summary include:
- Title, purpose and description of the investigation, as well as information on the design and methods used;
- Results and conclusions of the survey;
- Date of completion of the survey;
- Details of anticipated conclusions, temporary interruptions or suspensions of the survey.
Both documents, the clinical investigation report and its summary, must be accessible to the public via the electronic system on which they are uploaded, before the product is marketed.
To provide further guidance on the preparation of the summary of the clinical investigation report, the Commission issued the guidelines. As the MDR requirements are quite general, the Commission made sure to provide details on how the summary should be written. First, the Commission emphasizes that the summary is a document that should contain only the relevant information and a brief description of the investigation, as concisely as possible.
It is advisable – therefore – to consider the user’s level of knowledge and expertise in the health sector for which the device is intended. Depending on the specific area in which the product will be used, it may be necessary to use more or less technical language.
It emphasizes that the summary should not include any promotional content for the product.
It also provides a brief description of each item to be included in the summary of the report and, when relevant, indicates whether the approval of a specific ethics committee is required (as in the case of clinical investigations) and which guidance documents should be followed to correctly fill in a particular item. Finally, an essential diagram for describing and compiling the flow of participants is provided.
Following the requirements of the MDR and the Commission’s guidelines, sponsors can prepare a summary of the clinical investigation report that is clear, concise and conforms to established guidelines. This document will provide an understandable picture of the clinical investigation and its results for intended users and will be made publicly accessible through the electronic system.
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