WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices 6.3.1.1-CI: Sponsors obtain prior NRA authorization for new clinical investigations, run them under ethics committee oversight with informed consent to ISO 14155, and report progress and serious incidents

What does 6.3.1.1-CI require?

Any sponsor wanting to run a new clinical investigation should first obtain NRA authorization, and the investigation should be overseen by an institutional review board or local ethics committee to protect subjects (including informed consent), commonly following ISO 14155:2020 and the Declaration of Helsinki. Periodic progress reports and serious incidents during the investigation should be reported, and the NRA may suspend or stop an investigation where harm is identified. Market-acceptability studies of authorized devices (for example on ergonomics) are not clinical investigations, and in-country investigations should generally not be required where adequate foreign evidence and evaluation exist, unless there is a sound scientific reason.