Schedule 6 Clinical Investigation

This page provides an overview of this Schedule of the Medical Devices Rules 2017 and links to the official text.

Official source: MDR 2017 — CDSCO

Schedule 6 of the Medical Devices Rules 2017 sets out requirements for clinical investigations of medical devices in India. Key elements include: protocol development and ethical approval, investigator qualifications, informed consent procedures, adverse event monitoring and reporting, data integrity and record-keeping, clinical data analysis, and reporting timelines. Clinical investigations may be required for higher-risk devices, new technologies, or when non-clinical evidence is insufficient to demonstrate safety and performance.

Clinical investigations must be approved by an Institutional Ethics Committee (IEC) before commencement. The IEC must review and approve the clinical investigation protocol, informed consent forms, and investigator qualifications. All clinical investigations must comply with Good Clinical Practice (GCP) guidelines and the protocol must be registered with the Clinical Trials Registry - India (CTRI) where applicable.