Clinical investigations of medical devices carried out in human subjects to assure the safety and performance of a medical device meet the manufactures intended claim. It is my understanding the device to be investigated can be a new medical device or a device already in the market. Do any one agree on this?.
A clinical investigation of medical device is considered as the back born with data to prove safe use of device. Results of the investigation moved to clinical evaluation report to demonstrate safety and performance. ISO 14155:2011 addresses good clinical practice to perform Clinical Investigations of Medical Devices.
Any one can detail the requirement of ISO 14155:2011 compliance to Medical Device Clinical Evaluation for above 2 conditions.
Clinical investigation is a systematic investigation performed on one or more human subjects, in order to assess the safety or performance of a medical device. I agree that the device to be investigated need not be a new medical device. It can also be a device which is already in market, if there are any unanswered concerns regarding the device.
For clinical investigation of medical devices, the rules should be in accordance with International standards such as ISO 14155:2011, which addresses good clinical practice for clinical investigation and the results of the CI should be transferred to the clinical evaluation report. Clinical investigations not in compliance with medical device standards like EN ISO 14155 or comparable standards should not be used for demonstration of performance and/or safety of the device. The reasons should be noted in the report. In ISO 14155:2011, the requirements for proper conduct of clinical investigation, the responsibilities of the sponsor and principal investigator are clearly detailed for the safety and well being of humans.
Clinical Investigation is a clinical study or experiment in one or more human with purpose intended by manufacturer.
Yes, medical device under investigation can be novel or a device already in market.
Device is checked for safety, efficacy and side effects in clinical investigation following ISO 14155:2011 GCP for design, manage, document and reporting and respective results used as a part of CER for safety and performance demonstration as per MDR.
ISO 14155:2011 requirement’s compliance to Medical Device Clinical Evaluation are as follow
• Conduct of clinical investigation
• Suspension, termination and close of the clinical investigation
• Sponsor’s responsibilities
• Principal investigator’s responsibilities