WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices 6.2.2.2-DoC: Draw up, hold and supply on request a signed declaration of conformity for each device with the minimum content, and keep the supporting technical documentation available for verification

What does 6.2.2.2-DoC require?

The manufacturer, or whoever places the device on the market, should prepare, keep and submit or make available when required a written declaration that the device fully meets the law and all regulatory requirements, for every class. It should at least give the name and address of the person responsible for design or manufacture under whose name the device is supplied; the regulations it is made under; a description and the classification; a statement that the device is of good quality, safe and will perform as intended over its life when used as the instructions state; enough detail to identify the devices covered; the standards used to show conformity with the essential principles; and the signatory's name, role and signature with the date. Failing to make the declaration, or making a false one, is a ground for enforcement, and the NRA may verify it at any time, including at import, by examining the technical documentation.