According to the Medical Device Regulation (MDR), a clinical investigation is defined as:
"Any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device."
This definition encompasses a wide range of studies, including:
- Pre-market clinical investigations: These are conducted to obtain data necessary for CE marking and market authorization of a new medical device.
- Post-market clinical follow-up (PMCF) investigations: These are conducted after a device has been placed on the market to further assess its safety and performance.
It's important to note that clinical investigations under the MDR are subject to strict ethical and regulatory requirements, including:
- Ethical review: Clinical investigations must be approved by an independent ethics committee (IEC) or similar body.
- Informed consent: Participants must provide informed consent before participating in the study.
- Data protection: Data collected during the investigation must be protected in accordance with data protection regulations.
- Clinical investigation plan (CIP): A detailed plan must be prepared outlining the objectives, methodology, and risk management procedures of the investigation.
By adhering to these regulations, clinical investigations can help ensure the safety and efficacy of medical devices and contribute to improving patient care.