Artifact GuideEU

EU Low Voltage Directive Internal Production Control

For LVD equipment, the manufacturer uses Annex III internal production control: assess the product, compile the technical documentation, control production, sign the EU declaration, and affix CE marking.

No notified body participates in the LVD production-phase procedure. Another applicable Union act may impose a different conformity-assessment route.

Author
Sorena AI
Published
May 9, 2026
Updated
Jul 25, 2026
Sections
4

Structured answer sets in this page tree.

Primary sources
4

Cited legal and guidance references.

Publication metadata
Sorena AI
Published May 9, 2026
Updated Jul 25, 2026
Overview

is the conformity-assessment procedure required by Annex III of Directive 2014/35/EU. The manufacturer remains responsible for the product decision: confirm LVD scope, assess the Annex I safety objectives and product-specific risks, compile the technical documentation, keep production aligned with the assessed design, sign the EU declaration of conformity, and affix CE marking before placing compliant equipment on the market.

Section 1

What Module A requires from the manufacturer

Under Annex III, is a manufacturer-led procedure. The manufacturer ensures and declares on its sole responsibility that the electrical equipment satisfies the LVD requirements that apply to it. Testing may be performed by an external laboratory, but the manufacturer still owns the conformity decision and declaration.

A usable LVD release file connects four records: the product scope and safety-objective assessment; the technical documentation; the manufacturing controls that keep series production aligned with the assessed design; and the signed EU declaration with CE-marking evidence. A pass report without those links is not the complete Annex III record.

  • Confirm the product is electrical equipment within the LVD voltage bands and is not excluded by Annex II before using an LVD Module A file.
  • Map hazards to the Annex I safety objectives for persons, domestic animals, and property, including reasonably foreseeable use conditions.
  • Assign the manufacturer role carefully: an importer or distributor that places equipment on the market under its own name or trade mark, or modifies equipment in a way that may affect conformity, takes on the LVD manufacturer obligations.
  • Do not present a test laboratory report or voluntary certificate as an LVD notified-body approval. Annex III does not require notified-body participation, although another applicable Union act may require third-party assessment.
Section 2

Technical documentation contents

Annex III requires the manufacturer to establish technical documentation that makes it possible to assess conformity with the relevant LVD requirements. The file must include an adequate analysis and assessment of risks and cover, as relevant, the design, manufacture, and operation of the electrical equipment.

The technical file should allow a reviewer to reconstruct the conformity basis without relying on project memory. It should identify the model and assessed configuration, explain drawings and circuit schemes, connect tests and calculations to the safety objectives, and show which standards or other technical solutions address each material risk.

  • Keep a general product description, conceptual design and manufacturing drawings, component and sub-assembly schemes, and explanations needed to understand operation.
  • List harmonised standards applied in full or part and identify the parts applied when a standard is only partly used.
  • Where harmonised, international, or national standards are not used, describe the technical solutions adopted to meet the LVD safety objectives.
  • Attach design calculations, examinations, and test reports that identify the tested model, configuration, critical components, applicable limits, results, and unresolved deviations.
Section 3

Harmonised standards and safety objectives

Harmonised standards are voluntary. Compliance with a standard or part whose reference is published in the Official Journal gives a presumption of conformity only for the Annex I safety objectives covered by that standard or part. The Module A file should record the exact edition and amendments used, full or partial application, the covered risks, and any limitation or withdrawal date that affects the claim.

The file still needs a product-specific risk assessment. The LVD guide explains that a product may use techniques or present risks that were not addressed when a harmonised standard was drafted.

  • Check that each cited harmonised standard reference is published for the LVD and covers the relevant safety objective and product feature.
  • Record the product risks addressed by each standard and the risks handled through another technical solution.
  • When a standard is partly applied, identify the clauses or parts used instead of treating the whole standard as evidence.
  • Reopen the standards assessment after material design changes, safety-critical component substitutions, firmware changes affecting safety, test failures, complaints, or changes to the applicable Official Journal references.
Section 4

Manufacturing controls, EU declaration, and retention

The manufacturer must take the measures necessary so the manufacturing process and its monitoring keep manufactured equipment in line with the technical documentation and the applicable LVD requirements.

After conformity has been demonstrated, the manufacturer draws up the written EU declaration of conformity for the product model and affixes CE marking to each compliant item before it is placed on the market. The manufacturer must keep the declaration with the technical documentation available to national market surveillance authorities for 10 years after the equipment is placed on the market.

The release record should identify who approved the assessed design, who accepted test deviations, which production specification and inspection plan apply, which declaration revision covers the unit, and who verified the CE marking and required product information. A failed release check or unresolved safety gap stops the LVD release decision.

  • Tie production checks, inspection criteria, supplier controls, nonconformity handling, and change control back to the released technical documentation.
  • Keep the EU declaration continuously updated, translated as required by the Member State where the equipment is placed or made available, and traceable to the product model.
  • Use one EU declaration of conformity covering all applicable Union acts when the same equipment is subject to more than one act requiring such a declaration, and identify those acts and their publication references.
  • Prepare to provide conformity information and documentation in paper or electronic form after a reasoned request from a competent national authority, in a language the authority can easily understand, and cooperate on action to eliminate product risks.
  • If an authorised representative is used, document the written mandate. Under Annex III, the representative may perform the CE-marking and declaration duties in point 4 on the manufacturer's behalf and under its responsibility; the manufacturer still has to design and manufacture compliant equipment and draw up the technical documentation.
  • Reopen Module A after a material design, safety-critical component, firmware, intended-use, manufacturing, supplier, or standards-reference change, and after a test failure, production deviation, complaint, incident, or authority finding.
Recommended next step

Build the LVD Module A release file

Connect the scope decision, Annex I risk assessment, standards record, technical evidence, production controls, EU declaration, and CE-marking evidence for the released product model.

Primary sources

References and citations

single-market-economy.ec.europa.eu
Referenced sections
  • Commission overview confirming that harmonised standards are voluntary and that Official Journal publication is necessary for presumption of conformity.
ec.europa.eu
Referenced sections
  • Explains the technical documentation, risk analysis, manufacturing-control, declaration, CE-marking, and no-notified-body aspects of LVD Module A.
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