Definitions and explanations
Any systematic investigation or study in or on one or more human subjects,
This term is synonymous with ‘clinical trial’ and ‘clinical study’.
Clinical investigations include feasibility studies and those conducted for the purpose of gaining market approval, as well as investigations conducted following marketing approval.
Routine post market surveillance may not constitute a clinical investigation (e.g. investigation of complaints, individual vigilance reports, literature reviews).
Safety and/or performance information that are generated from the clinical use of a medical device.
Sources of clinical data may include:
(i) Results of pre- and postmarket clinical investigation(s) of the device concerned
(ii) Results of pre- and postmarket clinical investigation(s) or other studies reported in the scientific literature of a justifiably comparable device
(iii) published and/or unpublished reports on other clinical experience of either the device in question or a justifiably comparable device
The assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device when used as intended by the manufacturer.
This is a process undertaken by manufacturers of medical devices to help establish compliance with the relevant Essential Principles for safety and performance. The result of this process is a report that can be reviewed by conformity assessment bodies and regulators and which details the extent of available data and its quality and demonstrates how the compliance with the Essential Principles is satisfied by the clinical data. Clinical evaluation is an ongoing process - information about clinical safety and performance (e.g. adverse event reports, results from any further clinical investigations, published literature etc) should be monitored routinely by the manufacturer once the device is available on the market and the benefits and risks reassessed in light of this additional information.
The inputs for clinical evaluation are primarily clinical data in the form of clinical investigation reports, literature reports/reviews and clinical experience. The data required to establish the initial evidence of compliance with the Essential Principles may vary according to the characteristics of the device, its intended use, the claims made by the manufacturer, the existence and adequacy of warnings and other restrictions, and the extent of experience with its use. A key goal of the clinical evaluation is to establish that any risks associated with the use of the
device are acceptable when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety. The clinical evaluation will, therefore, also need to cross-reference risk management
The clinical data and the clinical evaluation report pertaining to a medical device.
Clinical evidence is an important component of the technical documentation of a medical device, which along with other design verification and validation documentation, device description, labelling, risk analysis and manufacturing information, is needed to allow a manufacturer to demonstrate conformity with the Essential Principles. It should be cross-referenced to other relevant parts of the technical documentation that impact on its interpretation.
In accordance with applicable local regulations, clinical evidence, in part or in total, may be submitted to and reviewed by conformity assessment bodies and regulatory authorities. The clinical evidence is used to support the marketing of the device, including any claims made about the clinical safety and performance of the device, and the labelling of the device.
Clinical evidence should be reviewed and updated throughout the product life cycle by the manufacturer as new information relating to clinical safety and performance is obtained from clinical experience during marketing (e.g. adverse event reports, results from any further clinical investigations, formal post market surveillance studies) of the device in question and/or comparable devices.