A manufacturer that, in a declaration (or anything connected with one) about applying conformity assessment procedures or comparable requirements to its own device, says something materially untrue or misleading commits an offence carrying 12 months' imprisonment or 1,000 penalty units; a civil penalty applies under section 41MHA. Declarations of conformity under Schedule 3 to the Medical Devices Regulations are the main documents concerned.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.