Another frequent question is whether a one time audit is enough. It is not. Product teams need technical documentation and declaration processes. Service teams need a living evidence pack that ties scope, requirements, tests, and statements together. Both need a way to answer procurement and authority questions quickly.
Teams also ask what happens if they fail. The directive leaves penalties to Member States, but for products it clearly gives market surveillance authorities power to require corrective action and, if necessary, restrict, prohibit, or withdraw non compliant products. Documentation failures are part of that risk.