A set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system. Under the IVDR: a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system. Section 2 Regulatory status of products and counselling.
Reference: MDR Article 2(71); IVDR Article 2(74)