Module A: internal production control
Under Annex VII, the manufacturer fulfils the obligations for technical documentation, manufacturing controls and the Declaration under its sole responsibility. The file must make it possible to assess conformity with the relevant requirements.
The structure should be proportionate to the packaging but specific enough to identify the type, components, design and intended conditions of use.
A practical technical-file structure
A useful working file groups stable packaging identity, construction and design information before mapping each applicable requirement to the assessment and evidence.
- General description and intended use
- Conceptual design, manufacturing drawings and component information
- Descriptions needed to understand the drawings and operation
- List of applicable requirements and technical specifications used
- Design calculations, examinations and assessment results
- Test reports and other supporting evidence
- Production-consistency controls
- Unresolved information and controlled next actions
Evidence quality and change control
Evidence should identify the exact material, component or packaging version it supports. Record the issuer, date, scope and any limitation. A broad marketing certificate should not be stretched beyond its stated scope.
Update the file when a component, supplier, design, intended use, standard or applicable legal requirement changes. Keep the version used for each Declaration traceable.
A generated technical file is not itself proof of conformity. The manufacturer must review the real evidence and carry out the assessment.