Guidance for Clinical Investigation Plan under MDR: Key Highlights!

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The latest guidance document from the Medical Device Coordination Group, MDCG 2024-3 – Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices, was just published.

The process of submitting an application for a clinical investigation under Article 70(1) of the Medical Device Regulation (MDR) requires careful adherence to the guidelines outlined in Chapter II of Annex XV. This includes the development of a comprehensive Clinical Investigation Plan (CIP) in accordance with the principles of good clinical practice as well as the latest scientific and technical knowledge. While compliance with the international standard ISO 14155:2020 is recommended for planning and conducting clinical investigations, it is essential to prioritize adherence to the legal requirements of the MDR. This guidance, developed collaboratively with input from national authorities, industry experts, and stakeholders, serves as a valuable resource for sponsors in navigating the complexities of CIP development, ensuring that all necessary information is included to support the successful conduct of the clinical investigation while meeting regulatory standards.

Feel free to reach out if you have any questions or require assistance and check our Legal Representative of the Clinical Investigation Sponsor service!