The #medicaldevices Coordination Group ( #MDCG ) released a guidance document on 08/05/2023 titled Commission Guidance on the Content and Structure of the Summary of the Clinical Investigation Report #clinical #clinicaldatamanagement #cro #pharamacovigilance

1. CLINICAL INVESTIGATION
SUMMARY
THE MEDICAL DEVICE COORDINATION GROUP (MDCG) RELEASED A
GUIDANCE DOCUMENT ON 08/05/2023 TITLED
COMMISSION GUIDANCE ON THE CONTENT AND STRUCTURE OF THE
SUMMARY OF THE CLINICAL INVESTIGATION REPORT
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2. Clinical Investigation Summary
- The document explains the conditions and requirements for health
institutions to manufacture and use medical devices without CE marking
under the MDR.
- The document provides examples of scenarios where the health
institution exemption under Article 5 of the MDR applies or does not apply.
- The document clarifies the roles and responsibilities of health
institutions, competent authorities, notified bodies, and manufacturers
about the health institution exemption.
- The document outlines the reporting obligations of health institutions
and the supervision measures of competent authorities regarding the
health institution exemption
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3. SPONSOR
EARLY
TERMINATION
CLINICAL
INVISTIGATION
PREPARE
REPORT+SUMMARY
Process Flow of Clinical Investigation Summary
SUBMIT
WITHING 90 DAYS OF
EARLY TERMINATION
SUBMISSION
TO THE MEMBER STATE THROUGH AN
ELECTRONIC SYSTEM
PUBLICLY ACCESS
REPORT+SUMMARY
PREPARE
REPORT+SUMMARY
SUBMIT
WITHING 365 DAYS OF
EARLY TERMINATION
SUBMISSION
TO THE MEMBER STATE THROUGH AN
ELECTRONIC SYSTEM
MARKET PLACEMENT
REPORT+SUMMARY TO GO TO PUBLIC
VIA ELECTRONIC SYSTEM
BEFOREMARKET PLACEMENT
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4. Electronic system on clinical investigation.
Information from the sponsor at the end of a
clinical investigation or in the event of a temporary
halt or an early termination.
Ethical principles and methods involved.
Article 73
Article 77
Annexure XV
Applicable Regulations
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5. Title of Investigation
Purpose of the Investigation
Description of the investigation
Results
Conclusion
Effective Clinical Invetigation summary
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6. 01 03 04
02
Decluttering
in 4 Easy Steps
No Copy Paste Keep
summary
Clean and
easy
Use Clear and
Professional
language
Don’t add any
Promotions in
summary
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7. VigilareBiopharma has been
assisting pharma companies
since 2014 in Regulatory,
Pharmacovigilance, and
Medical Devices in the
EUROPE UNION and USA
VigilareBiopharma
2014 Regulatory,
Pharmacovigilance
Medical Devices
EUROPE UNION USA
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