Clinical Investigation Report Template under EU MDR: CIR and Summary Requirements

A Clinical Investigation Report, or CIR, is the final report describing and critically evaluating the conduct, results and conclusions of a medical device clinical investigation. It must include all relevant data collected during the investigation, including negative findings.

The full CIR is not the same document as the summary required by Regulation (EU) 2017/745. Under MDR Article 77(5), the sponsor must submit both the full report and an accompanying summary to the Member States in which the investigation was conducted.

The standard deadline is one year after the end of the investigation. When an investigation is terminated early or temporarily halted, the deadline is three months. These obligations apply irrespective of the investigation outcome.

Clinical Investigation Report vs CIR Summary

Document	Purpose	Main regulatory source	Intended audience
Clinical Investigation Report	Provides a complete and critical evaluation of the investigation, including its conduct, methods, results, safety findings, limitations and conclusions.	MDR Article 77 and Annex XV, Chapter III, Section 7; applicable Good Clinical Practice requirements.	Sponsor, investigators, competent authorities, notified bodies and other regulatory reviewers.
Summary of the CIR	Presents the design, conduct, results and conclusions in a concise format that can be understood by the intended user of the device.	Commission Guidance 2023/C 163/06.	Intended users, regulators and the public.

Commission Guidance 2023/C 163/06 provides a structured format for the summary. It is not a complete template for the full Clinical Investigation Report. Sponsors therefore need a full CIR structure and a separate summary prepared for public disclosure.

Clinical Investigation Report Template: Practical Working Structure

The following structure can be used as a working outline for a medical device CIR. It should be adapted to the approved Clinical Investigation Plan, statistical analysis plan, device, investigation design and applicable national requirements.

CIR section	Information to include
Document control	Report title, investigation title, CIP number, CIV-ID, sponsor, version, date, confidentiality status, authors, reviewers and signatures.
Executive summary	Investigation rationale, design, population, device, primary objectives, headline results, safety findings and overall conclusion.
Background and objectives	Clinical background, device-development context, intended purpose, research question, objectives, hypotheses and endpoints.
Investigational device and procedures	Device identification, version or variant, components, comparator, instructions for use and investigation-specific procedures.
Investigation methods	Design, sites, eligibility criteria, interventions, sample-size justification, allocation, blinding, follow-up, monitoring, data collection and statistical methods.
Investigation conduct	Recruitment dates, participating sites, substantial modifications, temporary halts, early termination and relevant operational changes.
Participant disposition	Participants screened, enrolled, treated, completed, withdrawn and included in each analysis population, with reasons for exclusions and withdrawals.
Clinical performance or effectiveness results	Primary and secondary endpoint results, effect estimates, confidence intervals, sensitivity analyses and treatment of missing data.
Safety results	Adverse events, adverse device effects, serious adverse events, serious adverse device effects, device deficiencies, deaths and withdrawals related to safety.
Deviations and data quality	CIP deviations, protocol violations, missing data, monitoring findings and their effect on data integrity and interpretation.
Discussion and benefit-risk evaluation	Interpretation of findings, comparison with existing evidence, limitations, residual uncertainties and implications for the device benefit-risk profile.
Conclusions	Whether the objectives were met and what the investigation adds to the evidence supporting the device’s safety, clinical performance and intended purpose.
References and appendices	References, investigator list, statistical outputs, participant flow diagram, relevant tables and other supporting documentation.

This is a practical working structure rather than an official European Commission template. The final report must remain consistent with the approved CIP, statistical analysis plan, safety database, risk-management documentation and investigation records.

Summary Template under 2023/C 163/06

Commission Guidance 2023/C 163/06 defines the following structure for the summary accompanying the CIR:

Summary section	Required content
Cover page	Date, investigation title, sponsor and funding entity, CIV-ID or future EUDAMED identifier, and CIP number.
Investigation information	Brief and full study titles, start and end dates, locations and reasons for any temporary halt or early termination.
Purpose	Rationale, device background, condition addressed, current standard of care and alternative interventions.
Device, investigation and methods	Participants, device and comparator, procedures, design, objectives, endpoints, sample size, randomisation, blinding, follow-up, treatments, statistical methods and substantial modifications.
Results	Participant flow, baseline characteristics, primary and secondary results, safety outcomes and deviations from the CIP.
Conclusions	Benefit-risk interpretation, contribution to current scientific knowledge, limitations and potential future studies.

The summary should be concise and written for the intended user’s level of health literacy and numeracy. It must not contain promotional content or simply reproduce sections of the full CIR.

Results, analyses and conclusions should not be placed in the methods section. Where feasible, endpoint results should include absolute numbers, effect estimates and the precision of those estimates.

Safety outcomes should present aggregated adverse events, adverse device effects and device deficiencies in order of frequency. Both absolute numbers and percentages should be provided, together with whether events were expected or unexpected. Subject deaths, withdrawals and reasons for withdrawal must also be addressed.

Submission Deadlines and Current Publication Route

Situation	Maximum submission deadline
Investigation completed as planned	Within one year after the end of the investigation
Early termination	Within three months
Temporary halt	Within three months

The full CIR and its summary must be submitted together to the competent authorities of the Member States in which the clinical investigation was conducted.

The EUDAMED Clinical Investigations and Performance Studies module is not yet mandatory. Until that changes, sponsors must follow the applicable national submission procedures. Under MDCG 2024-15, the relevant Member State transmits the CIR and summary for publication in the European Commission’s public CIRCABC directory.

The documents are published in the form submitted by the sponsor. Neither the Member State nor the European Commission performs a later redaction. Sponsors are therefore responsible for confidentiality, personal-data protection and the content of both documents before submission.

The documents are tracked using the CIV-ID. The full report is identified as CIV-ID – CIR, while the summary is identified as CIV-ID – SCIR.

CIR Quality-Control Checklist

Before approving the final CIR and summary, verify that:

• Participant numbers reconcile across enrolment, disposition, analysis populations, endpoint tables and safety tables.
• Primary and secondary endpoints correspond to the approved CIP and statistical analysis plan.
• Negative, inconclusive and unexpected findings have not been omitted.
• Missing data, exclusions and analysis-set decisions are explained.
• Safety data reconcile with the safety database and competent-authority reports.
• Substantial modifications and CIP deviations are presented separately.
• Absolute numbers and percentages use consistent denominators.
• Benefit-risk conclusions are supported by the reported results.
• Promotional language has been removed from the public summary.
• Personal data and confidential information have been reviewed before submission.
• Document versions, dates, authors, reviewers and signatures are complete.

Relationship with ISO 14155:2026 and Safety Reporting

Commission Guidance 2023/C 163/06 refers to ISO 14155:2020 because that was the current edition when the guidance was published. ISO has since published ISO 14155:2026 as the current edition for the design, conduct, recording and reporting of medical device clinical investigations.

Sponsors should determine which edition applies to the investigation and document how the CIR reflects the approved study documentation and applicable Good Clinical Practice requirements. Our guide to ISO 14155:2026 explains the current edition and its implications for study conduct and reporting.

Safety tables in the CIR must also reconcile with the events and device deficiencies processed during the investigation. Our guide to MDCG 2020-10/1 safety reporting explains the reportable-event criteria, causality assessment, timelines and MDCG 2020-10/2 form.

MDx CRO supports medical device sponsors with medical writing, data management, biostatistics, safety reconciliation, Clinical Investigation Reports and public summaries. Explore our MedTech Clinical Solutions or contact our Clinical Research team to discuss an active or completed investigation.

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