Artifact GuideEU

LVD combined CE files

For many electrical products, the LVD file is not a standalone binder. The same model, label, instructions, standards list, and EU declaration may also need to support EMC, RED, RoHS, machinery, or market-surveillance requirements.

Use this page to keep declarations, standards, risk assessments, instructions, labels, and technical documentation consistent across the CE file instead of maintaining conflicting regime-by-regime records.

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

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Primary sources
7

Cited legal and guidance references.

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

A combined CE file for an LVD product should make one product story traceable across all applicable Union acts: what the product is, which acts apply, which standards or technical specifications were used, what risks were assessed, what tests support the claim, which instructions and labels ship with the product, and which declaration is available to authorities.

Section 1

Build the declaration around the product model

Start the combined file from the product model, not from separate compliance folders. LVD Article 15 requires the EU declaration to identify the Union acts concerned when more than one Union act requires a declaration, and the LVD guide explains that this single declaration can be a dossier made up of relevant individual declarations.

The declaration pack should therefore line up the same model, type, batch or serial identifiers, manufacturer or authorised-representative details, applicable Union acts, standards references, and signature authority. If an LVD product is also an EMC apparatus or radio equipment, the combined file should not let the LVD declaration name one product variant while the EMC or RED evidence names another.

  • Keep one declaration index that lists each applicable act, its publication reference, the product models covered, and the evidence folder that supports that act.
  • Use the LVD Annex IV fields as the traceability baseline: product identification, manufacturer or authorised representative, object of the declaration, relevant Union legislation, standards or other specifications, and signature details.
  • When individual declarations are kept as a dossier, make the relationship explicit so a market-surveillance request can find the LVD, EMC, RED, RoHS, or machinery evidence without guessing.
  • Do not put LVD on a machinery declaration where the LVD guide says the machinery declaration should refer to the Machinery Directive while the machinery still fulfils LVD safety objectives for electrical hazards.
Sources for this answer
Directive 2014/35/EU on electrical equipment within certain voltage limits
Supports the single EU declaration requirement, Annex IV declaration fields, and the manufacturer's responsibility for LVD conformity.
LVD Guidelines, August 2018
Explains that most LVD equipment is covered by other Union legislation and that a single declaration may be kept as a dossier of individual declarations.
Directive 2014/30/EU on electromagnetic compatibility
Grounds the same single-declaration and technical-documentation pattern for EMC apparatus.
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Review declarations, standards, risk files, instructions, labels, and technical documentation for LVD products that also touch EMC, RED, RoHS, machinery, or market-surveillance requirements.

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Section 2

Keep standards and risk evidence in the same matrix

The combined CE file should contain a standards matrix that separates what each standard is proving. LVD Annex III requires the technical documentation to include an adequate analysis and assessment of risks, the applicable requirements, applied harmonised standards or other specifications, design and manufacturing information, examinations, calculations, and test reports.

That matrix should show full or partial application of standards and should identify any essential requirement covered by a design solution instead of a cited harmonised standard. The same discipline matters for EMC and RED files because their technical documentation also relies on applicable requirements, risk assessment, standards, design evidence, and test results.

  • For each product model, map safety risks, EMC disturbances, radio essential requirements, substance-restriction evidence, and machinery electrical-hazard coverage to separate rows instead of one generic pass/fail statement.
  • For every harmonised standard, record the exact designation, version or date, whether it is applied in full or in part, the product variant tested, and the report or calculation that supports the claim.
  • When a standard is not applied or is only partly applied, describe the technical solution used to meet the relevant requirement and link it to test results or design analysis.
  • Review the standards matrix when product design, components, firmware, manufacturing controls, or OJEU standard references change.
Sources for this answer
Directive 2014/35/EU on electrical equipment within certain voltage limits
Annex III grounds the required LVD technical-documentation contents, including risk analysis, standards, drawings, calculations, examinations, and test reports.
European Commission harmonised standards overview
Supports the OJEU-publication and presumption-of-conformity context for harmonised standards.
LVD Guidelines, August 2018
Explains that LVD presumption of conformity is linked to OJEU publication and that standards use remains voluntary.
Section 3

Align instructions, labels, and economic-operator data

A combined CE file is weak if the shipped product contradicts the declaration. The LVD requires type, batch, serial or other identification, manufacturer contact information, CE marking, and instructions and safety information in a language easily understood by consumers and other end-users as determined by the Member State concerned.

For overlapping regimes, align the label artwork, package copy, user instructions, safety warnings, restrictions, importer details, and online product pages with the exact product scope in the declaration. EMC and RED have their own information-to-user requirements, so the combined file should identify which instruction or label field satisfies which act rather than copying one text block into every regime.

  • Keep the label master, packaging artwork, instruction manual, safety-information translations, and declaration identifiers under revision control with the technical file.
  • Check that importer and manufacturer contact details, model identifiers, CE marking placement, and language coverage match the product actually made available in each Member State.
  • For radio equipment, include the RED-specific user information, restrictions, accessories, software or firmware versions, and declaration access details where applicable to the product.
  • For distributors and importers, keep evidence that required documents, CE marking, instructions, and safety information were checked before the product was made available.
Sources for this answer
Directive 2014/35/EU on electrical equipment within certain voltage limits
Grounds LVD requirements for product identification, manufacturer contact information, CE marking, instructions, and safety information.
Directive 2014/53/EU on radio equipment
Supports RED-specific technical-documentation, user-information, declaration, and formal non-compliance alignment for radio products.
Directive 2014/30/EU on electromagnetic compatibility
Supports EMC requirements for instructions and information enabling apparatus to be used as intended.
Section 4

Make the file ready for market-surveillance access

The combined file should be structured for authority access, not only for internal approval. LVD requires manufacturers to keep technical documentation and the EU declaration for 10 years after placement on the market, and importers must keep a declaration copy and ensure technical documentation can be made available to authorities on request.

Regulation (EU) 2019/1020 adds a horizontal market-surveillance layer for products subject to Union harmonisation legislation. For covered products, an EU-established economic operator must verify that the declaration and technical documentation have been drawn up, keep the declaration available, ensure the technical documentation can be made available, provide information on request, inform authorities when a product presents a risk, and cooperate on corrective action.

  • Maintain an authority-request pack with the declaration index, technical-documentation table of contents, standards matrix, risk assessment, test-report register, label and instruction revisions, supplier declarations, and corrective-action log.
  • Assign the EU-established economic operator for the product and keep its name, registered trade name or trade mark, and postal contact details aligned with the product, packaging, parcel, or accompanying document as required.
  • Keep traceability records that identify who supplied the equipment and to whom it was supplied, so the combined file can support withdrawal, recall, or corrective-action decisions.
  • Treat missing declarations, incorrect declarations, incomplete technical documentation, absent CE marking, and inconsistent operator information as file defects that can become formal non-compliance findings.
Sources for this answer
Directive 2014/35/EU on electrical equipment within certain voltage limits
Supports the 10-year LVD retention period and authority access to technical documentation and declarations.
Regulation (EU) 2019/1020 on market surveillance and compliance of products
Grounds EU-established economic-operator tasks, market-surveillance requests, corrective action, and authority powers.
Commission Notice - Blue Guide on EU product rules (2022)
Provides general EU product-law context for CE marking, declarations, economic operators, conformity assessment, and market surveillance.
Primary sources

References and citations

Commission Notice - Blue Guide on EU product rules (2022)
eur-lex.europa.eu
Referenced sections
  • Provides general EU product-law context for CE marking, declarations, economic operators, conformity assessment, and market surveillance.
"The manufacturer is responsible for the conformity assessment"
Directive 2014/53/EU on radio equipment
eur-lex.europa.eu
Referenced sections
  • Supports RED-specific technical-documentation, user-information, declaration, and formal non-compliance alignment for radio products.
"user information and installation instructions"
European Commission harmonised standards overview
single-market-economy.ec.europa.eu
Referenced sections
  • Supports the OJEU-publication and presumption-of-conformity context for harmonised standards.
"references of harmonised standards are published"
LVD Guidelines, August 2018
ec.europa.eu
Referenced sections
  • Explains that LVD presumption of conformity is linked to OJEU publication and that standards use remains voluntary.
"the use of harmonised standards remains voluntary"
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