This template helps document Module A internal production control for electrical equipment under Directive 2014/35/EU.
It covers product identification, voltage scope, Annex I safety objectives, standards used, risk evidence, technical documentation, EU declaration, CE marking, instructions, labelling, production control, and change triggers.
Structured answer sets in this page tree.
Cited legal and guidance references.
This working template is for manufacturers documenting that electrical equipment meets the safety objectives of Directive 2014/35/EU before CE marking and market placement. It is not an official EU form and does not prescribe mandatory wording beyond the declaration elements in Annex IV. It follows Module A : the manufacturer establishes the technical documentation, assesses risks, controls manufacturing, draws up the EU declaration of conformity, and keeps the file available for market surveillance.
Start the record with enough product identity to match the technical file, label, EU declaration of conformity, packaging, customer documentation, and production records. The LVD scope check should record whether the equipment operates with an input or output voltage between 50 and 1000 V AC or between 75 and 1500 V DC.
The template should also capture every other Union act considered and the reason it applies or does not apply. Radio equipment within Directive 2014/53/EU follows RED rather than a separate LVD route, while a non-radio LVD product may also need an EMC or RoHS assessment. Where several applicable acts require an EU declaration, the declaration must identify all of them.
The assessment should map each relevant Annex I safety objective to the design feature, standard clause, calculation, inspection, or test evidence that demonstrates the objective has been addressed. Do not treat a harmonised standard reference as the whole assessment; record the parts applied and the residual evidence for safety objectives not fully covered by the selected standards.
For standards, identify whether the reference has been published in the Official Journal of the European Union for the LVD, whether it was applied in full or in part, and what technical solution was used where no applicable harmonised standard was used.
Use Sorena to check LVD scope, standards coverage, risk evidence, technical documentation, EU declaration content, CE marking records, instructions, labelling, and production-control triggers before market placement.
Use the risk and evidence table as the working index for the technical documentation. Each row should connect a hazard or safety objective to the evidence that proves the product design and manufacturing controls meet the applicable LVD requirement.
A reviewer should be able to move from any risk row to the drawings, calculations, component specifications, inspection records, test reports, instructions, labels, and production controls that support the conclusion.
The technical documentation section should mirror Annex III: general description, design and manufacturing drawings, explanations needed to understand the drawings and operation, standards or technical specifications used, design calculations and examinations, and test reports.
The EU declaration section should mirror Annex IV and identify the product, manufacturer, sole responsibility statement, object of the declaration, relevant Union harmonisation legislation, standards or technical specifications used, additional information, and signature details. Keep the EU declaration with the technical documentation for 10 years after the equipment has been placed on the market.
The release section should confirm that CE marking is applied only after conformity has been demonstrated, the EU declaration has been drawn up, and the technical file is complete enough to support the assessment. Record where the CE marking appears and why packaging or accompanying-document placement was used if the equipment or data plate is not suitable.
Production control should show how manufactured units remain aligned with the assessed design. The template should reopen when the design, component, supplier, production process, intended use, labelling, instructions, incident data, complaint trend, or applied standard changes in a way that may affect LVD conformity.
"The CE marking shall be affixed visibly, legibly and indelibly"
"The use of these standards remains voluntary."
"The manufacturer alone is responsible"