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If you’re conducting a clinical investigation of a medical device in an EU Member State, you will be required to submit a clinical investigation report (CIR) along with a summary of the CIR to that Member State.
EU MDR lists this as one of the requirements of a sponsor in Chapter VI, Article 77 of the regulation. However, EU MDR doesn’t specify the format of the CIR summary. It only notes that, “The Commission shall issue guidelines regarding the content and structure of the summary of the clinical investigation report.”
Well, those guidelines are finally here. The Medical Device Coordination Group released Guidance (2023/C 163/06) “on the content and structure of the summary of the clinical investigation report” in May 2023.
Here’s what it has to say about what to include in the CIR summary.
The clinical investigation report contains a detailed description of the study, the results of the investigation (including any adverse events) and a discussion of the overall conclusions. A full list of what must be included can be found in Annex XV, Chapter III of EU MDR.
But, as I noted earlier, the CIR must also be submitted with a summary. While the CIR summary will provide much of the same information, the guidance states that the summary must be written “in terms and in a format that are easily understandable to the intended user of the medical device.”
Not only that, but the guidance explicitly encourages brevity and concision in the writing of the summary document, stating that sponsors should “avoid simply copying bodies of text from the full clinical investigation report.”
In other words, don’t overthink the CIR summary—it really is meant to be a synopsis of the clinical investigation report.
The MDCG’s guidance document breaks the CIR summary into six sections:
The cover page will include the title of the clinical investigation, the sponsor, the entity funding the investigation, the ID number for the study, and the clinical investigation plan number.
The other sections are structured as follows:
This section of the CIR summary must include basic, but necessary, information about the study:
Here, you’ll briefly explain the hypothesis/hypotheses and purpose for your clinical investigation. Include some basic background information about the device that’s being studied and the condition it’s treating.
You may also need to describe the current standard of care for the condition and other possible interventions that could be used. You can think of this as the “why” behind your clinical investigation. What’s unique about your device? How could it potentially change current barriers of care for a given patient? In other words, why is your device necessary?
In this section of the CIR summary, you will be summarizing everything that went into the conduct of the clinical investigation, such as descriptions of:
It’s important to note that this is not the place to include results, analysis, conclusions, or discussion points. This is simply a concise description of the clinical investigation that was conducted.
This is the section where you summarize the outcomes of your clinical investigation. The guidance states that this should include:
Finally, you’ll use the last section of your CIR summary to discuss the results of your clinical investigation. Remember to keep this brief and clear, per the instructions at the beginning of the guidance.
This section will include brief answers to the questions:
The one thing you shouldn’t have to worry about as you write up your CIR summary is the quality of the data you’ve obtained from your clinical investigation. With so much riding on your clinical data, it’s crucial you have an electronic data capture (EDC) solution that’s built for your study’s needs.
That’s why we built Greenlight Guru Clinical specifically for MedTech. We knew the industry needed a tool that would allow MedTech companies to collect clinical evidence and safety and performance data—for any activity throughout the entire medical device lifecycle.
Our software comes pre-validated for both FDA and ISO 14155:2020 requirements to ensure you’re in compliance from the very beginning of your clinical investigation.
If you’re ready to see how a MedTech-specific clinical data solution can streamline your clinical investigation, then get your free demo of Greenlight Guru Clinical!
Stephanie Hinton is a Clinical Medical Device Guru with over a decade of combined experience working in human subjects research. Her expertise includes recruitment strategy, protocol development, IRB submissions and amendments, preparing for NIH grant applications, as well as coordinating and planning for DSMB...