MDCG 2024-3

?? Exciting News for the Medical Devices Clinical Investigations in EU! ????

In March 2024 a new Guidance on the content of the Clinical Investigation Plan (CIP) for clinical investigations of medical devices was published! ?? This comprehensive resource provides invaluable insights into crafting robust CIP’s which at the same time will comply with the most rigorous regulatory requirements and ensure the success of your clinical trials. ????

In the past, the Clinical Investigation Plan (CIP) was covered briefly in a paragraph of MEDDEV 2.7/4, But as of March 2024, the industry is expected to implement MDCG 2024-3. This guidance document is not legally binding, but it is “highly recommended” and recognized as best practice.

Key highlights include:

★ Scope and Objectives: Clearly define the scope and objectives of the clinical investigation, including the intended use of the medical device and the specific research questions to be addressed.

★ Study Design and Methodology: Describe the study design, methodology, and rationale for selecting particular endpoints, sample size, and statistical analysis plan. This should align with regulatory requirements and best practices in clinical research.

★ Patient Population and Recruitment: Specify the target patient population, inclusion and exclusion criteria, and strategies for patient recruitment, ensuring they reflect the intended use of the device and the study objectives.

★Identification and description of the investigational device: specifying its name, model, and version, as well as its intended use and technological features. Additionally, the guidance emphasizes the importance of accurately describing any modifications made to the device during the investigation process.

★Statements of compliance: including statements confirming adherence to applicable regulatory requirements and standards outlined in the Declaration of Helsinki. This includes compliance with relevant national and international regulations and legislation, such as EU MDR 2017/745, EN ISO 14155 standards, and Good clinical practice (GCP), as well as adherence to ethical considerations and patient safety requirements. The guidance stresses the importance of providing clear and comprehensive statements of compliance to ensure the integrity and validity of the clinical investigation.

★ Safety and Risk Management: Outline procedures for monitoring and managing device-related risks, including adverse events, complications, and patient safety measures. This should include protocols for reporting and addressing safety concerns throughout the study.

Whether you're a seasoned researcher or new to the field, this guidance offers invaluable support for navigating the complexities of medical device clinical investigations. ??

Check out the Clinical Investigation Plan Synopsis Template and the full guidance document to elevate your clinical trial planning and execution to the next level! ?? #MedicalDevices #ClinicalResearch #RegulatoryCompliance #HealthcareInnovation

Feel free to approach R.S NESS Group for assistance and consultation on planning and designing your clinical studies.