For a system subject to SoC: If there is a documented non-compliance with some detailed specification, does that automatically mean, it must not be put into operation, or can it be put into operation based on some evaluation criteria? If yes, which are these criteria?
For a system subject to SoC: If there is a documented non-compliance with some detailed specification, does that automatically mean, it must not be put into operation, or can it be put into operation based on some evaluation criteria? If yes, which are these criteria?
Answer
Considering that the detailed specifications are “soft law”, deviations to the detailed specifications (i.e., non-compliances) can be declared within the statement of compliance. Please refer to the associated AMC/GM Article 6 of the Delegated Act.
Last updated
04/01/2024