Clinical evidence requirements for medical devices
The TGA requires that manufacturers of all classifications of medical devices have clinical evidence. The level and type of evidence the TGA requires will vary depending on the medical device.
Clinical data may be:
- clinical investigation data
- data from all formal clinical trials carried out using devices
- any other experimental use in humans using prototype devices or components for the purpose of developing or investigating their safety and performance
- data from clinical experience, including:
- manufacturer-generated post market surveillance reports, registries or cohort studies
- adverse events databases
- data for the device in question generated from individual patients under Authorised Prescriber and/or Special Access Schemes prior to marketing of the device
- details of clinically relevant field corrective actions (eg recalls, notifications, hazard alerts)
- data, both favourable and unfavourable, obtained from a review of the literature:
- specifically about the device in question - where available, this must always be included in any review, and/or
- for comparative and well-established devices this must include relevant post market information
- if clinical data is not available adequate justification should be provided to explain how data for a similar device can establish the safety and performance of the device in question.
Clinical data that is not acceptable includes but is not limited to: brochures, testimonials and product description.
Manufacturers must:
- demonstrate compliance with Essential Principle 14 relating to clinical evidence
- compile clinical data
- arrange for a signed and dated clinical evaluation report to be prepared by an expert.
The TGA will:
- ensure compliance with the relevant legislation, including Essential Principle 14
- assess the clinical evaluation report against the clinical data if and when requested from the manufacturer.
The TGA may seek the advice of the Medical Device Evaluation Committee, to provide expert advice in relation to the medical device and the documented:
- performance
- safety
- benefit/risk assessment
- compliance with the TGA legislative requirements.
For more information, please see the Clinical evidence requirements for inclusion of medical devices in the ARTG <http://www.tga.gov.au/docs/html/devguid4.htm>.