In March, the Medical Device Coordination Group (MDCG) published the Guidance on the content of the Clinical Investigation Plan for clinical investigations of Medical Devices which deals with clinical investigations taking into account the latest technical knowledge and, concerning safety, benefit-risk performance of devices.

In general, a clinical investigation must include enough observations to ensure the scientific value and validity of the conclusions. Furthermore, the research procedures and methodologies used to perform the clinical investigation must be appropriate for the investigated device.

Specifically, the clinical investigation plan (CIP) defines the rationale, objectives, design methodology, monitoring, conduct, record keeping and analysis method for the clinical investigation. The CIP must be sufficiently detailed to serve as a manual for those conducting the clinical investigation.

In addition, the CIP must allow competent authorities and ethics committees to assess whether the clinical investigation has been designed in such a way that the potential risks for subjects or third parties are justified with the expected clinical benefits. Finally, the CIP must make it possible to assess whether the reliability and robustness of the data to be generated in the clinical investigation justify the exposure of subjects to the experimental device and procedures described in the CIP.

The CIP must contain several elements such as:

  • a summary description of the investigational device;
  • a description of the potential benefits of the investigation and any risks to which subjects will be exposed while participating in the clinical investigation;
  • the purpose of the clinical investigation;
  • statements regarding the clinical performance, efficacy or safety of the investigational device to be tested;
  • selection criteria;
  • the size of the population to be investigated;
  • information on vulnerable subjects involved such as children, pregnant women, immunocompromised subjects or the elderly.

Among other aspects, it is noted in particular that within the clinical investigation plan it must be apparent that the competent authority must be informed of any proposed changes that could substantially affect the safety, health, or rights of the subjects.

These are just some of the aspects addressed in the MDG guidance.

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Guidance on the content of the Clinical Investigation Plan for clinical investigations of Medical Devices