Annex II requires technical documentation that makes it possible to assess conformity and includes an adequate analysis and assessment of risks. For EMC, the record should connect design, manufacture, operation, standards, assessment results, test reports, and the EU declaration of conformity into one traceable evidence set.
The technical file is also the place to show acceptance and remediation evidence. If testing or assessment reveals a non-conformity, record the failed configuration, disturbance or immunity issue, root cause, design or installation change, retest evidence, updated instructions, and approval to release. Manufacturers, importers, and distributors have corrective-measure duties when they know or have reason to believe apparatus is not in conformity, so the remediation log should be specific enough to support withdrawal, recall, authority response, or continued release decisions.