MDCG 2024-3: A New Benchmark for Clinical Investigation Plans

·         Rigorous Guidance: MDCG 2024-3 sets forth detailed guidelines for the content of Clinical Investigation Plans (CIP) for medical devices, emphasizing safety, efficacy, and compliance.

·         Enhanced Clarity: Offers a structured approach to documenting investigational devices, including their benefits, risks, and technical features, ensuring transparency and robustness in clinical investigations.

·         Strategic Design: Stresses the importance of strategic study design, including objectives, hypotheses, and statistical considerations, to optimize clinical trial outcomes and data integrity.

·         Comprehensive Coverage: Covers all aspects of a CIP, from ethical considerations and informed consent to data management and adverse event reporting, ensuring comprehensive oversight throughout the clinical investigation lifecycle.

🔗 Original: https://health.ec.europa.eu/document/download/690de85a-ac17-45ea-bb32-7839540c25c4_en?filename=mdcg_2024-3_en_0.pdf