Australia Therapeutic Goods (Medical Devices) Regulations 2002 r3.11-sch3-8: Apply the clinical evaluation procedures to every device (custom-made devices included): obtain clinical investigation data or a documented literature review, evaluate it through competent clinical experts and document the clinical evidence in writing

What does r3.11-sch3-8 require?

Beyond the class-based procedures, the clinical evaluation procedures in Schedule 3 Part 8 apply to every device other than most exempt devices, clinical trial approvals and authorised prescriber supplies, and they do apply to custom-made devices. The manufacturer must obtain clinical data by clinical investigation, literature review or both, taking account of applicable standards. Clinical investigation data comprises the documents on design, approval, conduct and results of each human investigation, the observational and measurement record (in a form that can be independently verified) and an expert's critical evaluation; Australian investigations must follow the NHMRC National Statement on Ethical Conduct in Research Involving Humans and overseas ones the Declaration of Helsinki. A literature review is a compilation, by a documented method, of published and unpublished, favourable and unfavourable literature covering expert opinion, hazards and misuse and performance, with an expert's critical evaluation. The manufacturer must have competent clinical experts evaluate the data and must document in writing the clinical evidence showing the essential principles are met.