The audit file should not merely say that Annex I was considered. It should show the cybersecurity risks against which the product is designed, developed, produced, delivered, and maintained, and then explain how each applicable Annex I Part I requirement is implemented.
The Commission FAQ clarifies that the cybersecurity risk assessment covers the whole product with digital elements, including remote data processing when in scope, and supports planning, design, development, production, delivery, and maintenance. Keep the assessment tied to intended purpose, reasonably foreseeable use, conditions of use, and the time the product is expected to be in use.