MDCG Guidance on Clinical Investigation Plans

The Medical Device Coordination Group (MDCG) has published guidance on content for the Clinical Investigation Plans.

What are the key points?

• • Ethical Considerations: Emphasis is placed on adhering to good clinical practice, legal requirements, and ethical standards to safeguard the well-being of study subjects and ensure their protection.
  • Content: Each section of a clinical investigation plan is outlined, and detailed explanations are provided.
  • Benefit-Risk Analysis: The importance of a complete and thorough benefit-risk analysis is emphasized. Benefits to study subjects need to outweigh the risks.
  • Post-Investigation Follow-ups: Guidance on subject management post-participation with particular emphasis on monitoring and care when devices are intended to remain with subject post-study completion.

You can read the entire Clinical Investigation Plan document here.

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