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Artifact TemplateEU

LVD Conformity Assessment Template

This template helps document Module A 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.

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Author
Sorena AI
Published
May 9, 2026
Updated
Oct 15, 2026
5 sections3 primary sources
Overview

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.

Section 1

Product and voltage scope fields

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.

  • Product name, model, type, batch or serial number, hardware revision, firmware or software version if it affects electrical safety, and product image when useful for traceability.
  • Manufacturer name, registered trade name or trade mark, postal contact address, authorised representative if used, importer if known, and intended EU market.
  • Rated input and output voltage, AC or DC classification, supply method, accessories, power supply unit, cables, and any configuration limits that keep the equipment inside or outside LVD voltage scope.
  • Intended use, reasonably foreseeable use, installation environment, user group, maintenance assumptions, and exclusions from the assessment.
  • List of other Union acts considered, the product fact that controls each applicability decision, the evidence owner, and whether a single EU declaration of conformity will cover the applicable acts.
  • Conformity route and responsibility: Module A owner, technical-file approver, manufacturing-control owner, declaration signatory, and any authorised representative's written mandate. Do not add a notified-body field as if third-party intervention were mandatory under the LVD.
Section 2

Annex I safety objectives and standards used

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.

  • Annex I objective: protection against hazards arising from electrical equipment, including insulation, earthing, enclosure, temperature, fire, mechanical, radiation, and non-electrical hazards relevant to the product.
  • Standard record: standard number, title, edition, amendment, OJEU reference status, full or partial application, clauses applied, clauses excluded, and reason for any exclusion.
  • Alternative solution record: engineering rationale, design calculation, component rating, inspection method, test method, acceptance criteria, and reviewer approval.
  • Presumption of conformity note: only the safety objectives covered by the OJEU-published harmonised standard reference should be marked as covered by that standard.
  • Standards-change check: owner and date for checking whether selected harmonised standards, international standards, national standards, or other specifications have changed before release or significant redesign.
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Review an LVD technical file before release

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.

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Section 3

Risk and evidence table

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.

  • Column 1 - hazard or safety objective: electrical shock, energy hazard, overheating, fire, mechanical stability, ingress, misuse, installation error, maintenance exposure, or other product-specific issue.
  • Column 2 - applicable requirement: Annex I objective, harmonised-standard clause, international or national standard provision, or other technical specification.
  • Column 3 - design control: protective enclosure, insulation system, creepage or clearance control, protective earthing, component rating, thermal cut-out, fuse, warning, installation condition, or other design measure.
  • Column 4 - evidence: design drawing, bill of materials, safety calculation, component certificate or specification, inspection result, test report, risk assessment note, user instruction, label artwork, or production record.
  • Column 5 - result and owner: pass, conditional pass, open issue, corrective action, responsible function, evidence location, release approval, and next review trigger.
Section 4

Technical documentation and EU declaration fields

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.

  • Technical file index: general product description, block diagram, circuit schematics, PCB or wiring drawings, mechanical drawings, manufacturing drawings, critical component list, operating description, and installation conditions.
  • Risk and verification evidence: Annex I mapping, standards matrix, calculations, examinations, test reports, nonconformity closure records, and residual issue approvals.
  • EU declaration of conformity: declaration number if used, product model or type, manufacturer or authorised representative address, sole responsibility statement, object identification, Union acts, standards or specifications, signer name, function, place, date, and signature.
  • Retention and access: file owner, storage location, language handling, version history, and process for supplying the EU declaration or technical documentation to market surveillance authorities when requested.
  • Single declaration check: where several Union acts require an EU declaration of conformity, record whether one declaration covers all applicable acts and lists their publication references.
Section 5

CE marking, instructions, labelling, production control, and change triggers

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 supports the assessment. Record the marking on the equipment or data plate. If that is impossible or unwarranted because of the equipment's nature, record CE marking on both the packaging and the accompanying documents, with the reason for using that fallback.

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.

  • CE marking record: artwork, location on equipment or data plate, or on both packaging and accompanying documents where the equipment's nature justifies that fallback; visibility, legibility and indelibility checks; confirmation it is applied before placing on the market.
  • Instructions and safety information: required languages for each Member State market, installation instructions, use limitations, maintenance warnings, electrical ratings, protective measures, and safety information review.
  • Labelling and traceability: type, batch or serial number, manufacturer name, trade name or mark, postal contact address, importer details where relevant, rating plate, warnings, packaging label, and accompanying document references.
  • Production control: manufacturing process controls, incoming inspection for safety-critical components, final electrical safety checks, sample testing where risk warrants it, complaint and recall register, and distributor information process.
  • Change triggers: design or characteristic change, critical component substitution, supplier change, production process change, new or revised applied standard, test failure, safety complaint, nonconforming product, recall, authority request, or new intended-use claim.
Primary sources

References and citations

Directive 2014/35/EU on electrical equipment within certain voltage limits
data.europa.eu6 citations
Referenced sections
  • Primary legal source for LVD scope, manufacturer obligations, Module A internal production control, technical documentation, EU declaration of conformity, CE marking, instructions, labelling, retention, and production controls.
  • Supports the product traceability, manufacturer identity, conformity assessment, technical documentation, EU declaration, and CE marking fields.
  • Supports Annex I safety-objective mapping, Article 12 presumption of conformity, and the Annex III requirement to list standards applied in full or in part.
Show 3 more
  • Supports the requirement that technical documentation include adequate risk analysis and assessment plus design, manufacture, operation, calculations, examinations, and test reports.
  • Supports the Annex III technical documentation content, Annex IV EU declaration model, and 10-year availability requirement.
  • Supports CE marking placement, instructions and safety information, traceability markings, production conformity procedures, and change-control triggers.
"Internal production control is the conformity assessment procedure"
More quoted passages
"the safety objectives referred to in Article 3 and set out in Annex I"
"an adequate analysis and assessment of the risk(s)"
"The manufacturer shall establish the technical documentation."
"The CE marking shall be affixed visibly, legibly and indelibly"
European Commission - Low Voltage Directive policy page
single-market-economy.ec.europa.eu3 citations
Referenced sections
  • Commission source for LVD scope, implementation guidance, standards links, notified-body position, voluntary-certificate warning, and CE marking context.
  • Supports the LVD voltage scope and Commission implementation context for electrical equipment.
  • Supports the Commission warning that LVD compliance is not proven by voluntary certificates and that CE marking follows testing and the applicable conformity assessment procedure.
"The manufacturer alone is responsible"
More quoted passages
"input or output voltage"
European Commission - harmonised standards overview
single-market-economy.ec.europa.eu2 citations
Referenced sections
  • Commission source for harmonised standards, OJEU publication of references, voluntary use, and presumption-of-conformity context.
  • Supports the voluntary nature of harmonised standards and the need to check OJEU-published references.
"The use of these standards remains voluntary."

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