Table 7.

Structure of the GSPR Checklist to be Filled for Evidence of Compliance with Annex I of the EU IVDR.

No	General safety and performance requirement according to Annex I, IVDR	A/NA	Method used to demonstrate conformity	Method reference	Reference to the identity of controlled documents within the QMS	Justification for applicability/non-applicability
1	Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. They shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art	A	Compliance with international standards	ISO 15189 (whole standard); ISO 22367, 5.4, 5.5, Annex A.4, Annex D; ISO 13485, 7.3	Quality manual, documented procedures for the design and development process for LDTs including validation and verification procedures	Requirement is fully applicable for LDTs, because performance and safety are essential throughout the lifecycle of each LDT
…	…	…	…	…	…	…

Only few IVDR requirements can be fully covered (italic) by compliance with ISO 15189

The checklist is applied to the General Requirement No. 1 of Annex I of the EU IVDR. A method used to demonstrate conformity could be, for example, the application of an international standard, specifications etc. The method reference is, for example, the title of a standard. The reference to the QMS could be the identifier of an SOP, for example

A applicable requirement, NA not applicable