Medical Device manufacturers in the EU must abide by the EU Medical Device Regulation (MDR), which sets requirements for demonstrating the safety and performance of devices before they are placed on the market. Clinical investigation is a crucial part of the conformity assessment process for higher-risk medical devices (Class IIb, Class III, and certain Class IIa devices). Article 77(5) of the MDR mandates that the sponsor of a clinical investigation must submit a comprehensive Clinical Investigation Report to the relevant Competent Authorities within one year of the clinical investigation's conclusion or within three months of its early termination. Along with the full report, the sponsor is also required to provide a Summary of the Clinical Investigation Report.
The purpose of the Summary is to provide an easily understandable overview of the essential aspects of the clinical investigation. It should include the design, conduct, analysis, and results of the study in a concise format, making the information accessible to the intended users of the medical device. The summary serves as a way for the public and regulatory authorities to gain insights into the key findings of the clinical investigation without having to go through the full report, which may contain technical or specialized terminology.
Key Elements of the Summary
1. Title of the Clinical Investigation:
The summary must include the title of the clinical investigation, which should be concise yet descriptive enough to provide an overview of the study's scope and purpose.
2. Purpose of the Clinical Investigation:
This section should outline the primary objective of the clinical investigation, detailing what the study aims to achieve and the specific questions it seeks to address.
3. Description of the Investigation, Investigational Design, and Methods Used:
Here, the summary should provide a brief overview of the study design, including the type of investigation (e.g., randomized controlled trial, observational study) and the methods employed for data collection and analysis.
4. Results of the Investigation:
The most critical section of the summary, this part should present the key findings of the clinical investigation. Succinctly highlight the outcomes, efficacy, safety data, and any other relevant results that are essential for understanding the device's performance.
5. Conclusion of the Investigation:
The summary should conclude with a brief but comprehensive statement summarizing the overall outcome of the clinical investigation and its implications for the device's safety and effectiveness.
Guidance for Developing the Summary
1. Be Concise and Relevant:
The summary should only include relevant information, avoiding extensive details or verbatim copying from the full clinical investigation report. Focus on providing the most critical data to allow readers to grasp the study's main findings efficiently.
2. Tailor the Language to the Intended User:
Consider the health literacy and numeracy levels of the intended users while developing the summary. Use clear and straightforward language that can be easily understood by the device's potential users.
3. No Promotional Content Allowed:
The summary should not contain any promotional content, as its purpose is to objectively present the clinical investigation results without any bias.
For further information, the content and structure of the Summary of the Clinical Investigation Report are outlined in Section 7, Chapter III of Annex XV of the MDR. This section specifies what information should be covered in the Summary, including the title of the clinical investigation, its purpose, a brief description of the investigational design and methods used, the results of the investigation, and the overall conclusion.
The summary, along with the full Clinical Investigation Report, should be submitted electronically to the Member States where the clinical investigation took place, using the electronic system referred to in Article 73 of the MDR. Ultimately, the Summary of the Clinical Investigation Report is a vital tool for ensuring transparency and making critical information about the safety and effectiveness of medical devices publicly accessible while aligning with the regulatory requirements set forth by the EU MDR 2017/745.
The Commission guidance on the content and structure of the summary of the clinical investigation report is a critical tool in ensuring transparency and accessibility of medical device evaluation data. By adhering to these guidelines, sponsors can effectively communicate the key outcomes of the clinical investigation in a manner that benefits both regulatory authorities and potential users of the medical device.
Link to the guide:
EUR-Lex - 52023XC0508(01) - EN - EUR-Lex (europa.eu)
References:
1. Regulation (EU) 2017/745 Article 77(5)
2. Regulation (EU) 2017/745 Article 77
3. Regulation (EU) 2017/745 Annex XV, Chapter III, Section 7
4. MDCG guidance document 2021-6: Questions & Answers regarding clinical investigation
5. International standard EN ISO 14155:2020 Annex D.7
6. Regulation (EU) 2017/745 Article 80
7. Regulation (EU) 2017/745 Article 2
8. Regulation (EU) 2017/745 Annex XV, Chapter II, Section 2.5
9. International standard ISO 14155:2020 Annex D.8