WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices 4.3.1-clinical: Compile clinical evidence and a documented clinical evaluation under the QMS as part of the technical documentation, with new data for novel high-risk devices and investigations to ISO 14155

What does 4.3.1-clinical require?

Clinical evidence forms part of the technical documentation that, with verification and validation records, the device description and labelling, the risk analysis and production information, demonstrates conformity with the essential principles. The manufacturer should describe the device's inherent risks and benefits and the uncertainty in them, and should evaluate, thoroughly and in writing, every piece of available clinical data under its QMS; the resulting report sits in the technical documentation and informs whether a new clinical investigation is needed. Literature, clinical experience, post-market data and adverse event data on earlier versions may be enough for well-established technology without new risks or uses, but high-risk devices with new designs, materials or software need new evidence. Clinical investigations are commonly run to ISO 14155:2020. Class C and D submissions should include clinical evidence; for Class B it should be available on request.