The manufacturers requirement to conduct clinical trial and collect data on the usage of the devices is important in areas of pharmacovigilance and market surveillance. Medical device database contains all clinical information on the lifecycle and use of the product.
Medical device is an apparatus, instrument or machine used for the purpose of measuring, detecting or predicting, restoring or correcting, modifying the structure or body function for certain health treatments, diagnosis or prevention of disease. The classification of devices is based on invasiveness, intended use, duration of use, risks and potential harms associated with medical devices. An implant cardfor patient with implanted medical devices contains the name, serial number and batch code of the device along with UDI, device model and relevant precautions or warnings. A UDI or unique device identifier enables easier traceability of medical devices.
A clinical investigation or trial of a medical device is defined as a systematic study on human subjects undertaken to assess the performance or safety. Clinical trials for medical devices are conducted predominantly to identify safety and effective performance of prostheses (artificial body parts); simple adhesive bandages; surgical, monitoring or diagnostic equipments and advanced implanted devices such as pacemakers in prevention, diagnosis or treatment of diseases. The need to conduct clinical trials relies on the class; substantial similarity to approved device is determined and clinical data to support the new device is usually published in medical literature.
Clinical trials conducted on pharmaceuticals and medical devices are similar but differently designed or executed and regulatory evaluation of devices is distinct from that of drugs. The number of subjects in a device trial needed to demonstrate the effectiveness and safety are lesser than drug trials. Clinical evidence demonstrates consistency and accuracy in the level of effectiveness that meets application requirements labelled on the device. The proposed study on the new device undergoes review and notification process before beginning the clinical trials for the purpose of ensuring the safety of the participating subjects.
Feasibility clinical investigation in early device development is limited to initial device design before finalisation for a specific use. A prototype device will undergo a cycle of preclinical testing and redesigning for a refined and tested design ready for production and testing in humans. Pilot clinical investigation is commonly used to capture preliminary information on effectiveness and safety on the device design to adequately plan an appropriate pivotal study designed to collect definitive statistical evidence on effectiveness and safety of the device used in a justified number of participants. Post-approval clinical investigations are conducted after regulatory approval of the product for marketing.Surgical implant based medical devices cannot be inserted into healthy subjects and device trials are initiated by small pilot study before moving into larger pivotal population with the disease.
The sponsor in medical device trials includes at least one imaging modality to enable viewing and ensure intended functioning of the device. Manufacturers of implantable and in vitrodiagnostics devices need to maintain safety reports on health effects directly or indirectly related to the device. The health condition not related to the device but experienced by the participant during the trial also needs to be reported. Device trials requires health professionals like study doctor, psychologists, physiotherapists investigator, clinical trial coordinator, device technician or programmer, medical imaging or pathology staff depending on the device and trial design. The evaluation of the safety and efficacy of the device requires hands-on device and protocol training of the investigator and site staff.
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