MDCG 2023-4 guidance - content of the Clinical Investigation Plan (CIP)

📣 MDCG issued a new document

"MDCG 2024-3: Guidance on content of the Clinical Investigation Plan (CIP) for clinical investigations of medical devices"

It provides comprehensive guidance for developing a Clinical Investigation Plan (CIP). This document is crucial for sponsors planning and conducting clinical investigations of medical devices to ensure safety, performance, and compliance with the Medical Devices Regulation (MDR) (EU) 2017/745.

Key highlights of the document include:

1️⃣ Introduction and Purpose: It outlines the importance of a well-prepared CIP based on the latest scientific knowledge and technical advancements. The CIP must confirm or refute the manufacturer's claims regarding the device's safety, performance, and benefit-risk determination, ensuring an investigation's scientific validity.

2️⃣ Content of the CIP: Detailed guidance on what should be included in a CIP, covering aspects such as the investigational device's identification, description, benefits, risks, and the benefit-risk ratio. It emphasizes the need for a clear investigation rationale, objectives, hypotheses, design, and methodologies that comply with good clinical practice (GCP) and relevant standards like ISO 14155:2020.

3️⃣ Design and Conduct of Clinical Investigations: Recommendations on the design, including type of investigation, selection criteria, population size, bias minimization strategies, statistical design, data management, and monitoring plans to ensure robustness, reliability of data, and subject safety.

4️⃣ Compliance and Ethical Considerations: Stresses compliance with ethical principles, MDR, and other relevant standards. It highlights the necessity of obtaining informed consent, ensuring subject safety, managing adverse events, and fulfilling regulatory and ethical obligations regarding the investigation's conduct, modifications, and termination.

5️⃣ Post-Investigation Requirements: Discusses arrangements for subjects post-participation, publication policy, technical and functional features of the device under investigation, and a bibliography of references related to the clinical investigation.

This document serves as a critical resource for sponsors to develop their CIPs, ensuring that clinical investigations are conducted ethically, scientifically, and in compliance with regulatory requirements, ultimately facilitating the assessment of medical devices' safety and effectiveness before their market entry.

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European Regulation for Medical Devices MDR 2017/745 have added new requested requirements and these requirements form part of the documentation to be presented to the notified body (e.g. review of the in-depth clinical evaluation, PMS procedure, QC results from validation products, proof of staff skills, etc.).

CSDmed brings its expertise and a methodical approach to its clients, start-ups, manufacturers, importers and distributors of medical devices, thanks to a team of specialized experts and consultants, who will be able to address the MDR dossiers in their entirety

🔗 Contact us and find out how we can help you.