Glossary Term
Clinical Investigation
Definition
A Clinical Investigation is a systematic study involving human participants conducted to evaluate the safety, performance, and clinical benefits of a medical device. These investigations are essential for generating evidence required to support regulatory approvals, demonstrate compliance with standards, and ensure patient safety.
Relevance to the MedTech Industry
Clinical Investigations are critical for establishing the evidence base needed to bring innovative medical devices to market. They provide real-world data on how devices perform under intended use conditions, ensuring they meet safety and efficacy standards while addressing unmet clinical needs.
Additional Information & Related Terms
Good Clinical Practice (GCP) A set of standards ensuring the ethical and scientific quality of clinical investigations.
Post-Market Clinical Follow-Up (PMCF) A type of clinical investigation conducted after device approval.
Clinical Evaluation Plan (CEP) Outlines how clinical investigations fit into the broader clinical evaluation process.
Clinical Evaluation Report (CER) Summarizes and analyzes data collected during clinical investigations.