CE MarkingEU

EU LVD 2014/35/EU Conformity Assessment and CE Marking

Build the evidence chain from Annex I to CE marking.

Output: technical file + EU Declaration of Conformity + CE marking evidence you can retrieve fast.

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Author
Sorena AI
Published
Feb 21, 2026
Updated
Feb 21, 2026
Sections
6

Structured answer sets in this page tree.

Primary sources
4

Cited legal and guidance references.

Publication metadata
Sorena AI
Published Feb 21, 2026
Updated Feb 21, 2026
Overview

For the LVD, conformity assessment is normally the manufacturer's responsibility under Module A, internal production control. There is no routine notified body route under the directive itself. The real deliverable is an evidence chain that shows how Annex I safety objectives are met, how the technical file supports that conclusion, and how the DoC, CE marking, traceability, and language obligations are controlled at release.

Section 1

1) The LVD conformity assessment model

Directive 2014/35/EU uses Module A in Annex III. That means the manufacturer designs the conformity assessment system, performs or commissions the necessary assessment work, and holds the evidence.

The main operational question is not whether a certificate exists. It is whether the evidence chain is coherent, current, and accessible.

  • Start with a scope memo confirming voltage limits, exclusions, and overlap with other acts.
  • Build an Annex I hazard map and choose the standards or other technical specifications used to meet each relevant safety objective.
  • Compile Annex III technical documentation and then draw up the DoC and affix CE marking.
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Section 2

2) Step by step CE workflow

Use this as the internal release sequence before shipping or listing products in the EU.

Each step should have an owner, evidence location, and go or no go decision.

  • Confirm product scope and economic operator roles.
  • Lock the standards register and the test plan based on the actual shipped configuration.
  • Finish testing, calculations, and risk analysis, then update the technical file index.
  • Issue and sign the DoC, verify markings and instructions, and archive the release pack.
Section 3

3) Technical documentation as the source of truth

Annex III makes the technical documentation the core artifact. It must make it possible to assess conformity and include an adequate analysis and assessment of risk.

If the technical file is weak, the DoC and CE mark are weak as well.

  • Include product description, drawings and schematics, explanations, standards list, calculations, examinations, and test reports where applicable.
  • Document standards applied in full or in part, and explain alternative solutions where harmonised standards are not used.
  • Keep the technical file version linked to the exact type, batch, serial logic, and shipped configuration.
Section 4

4) EU Declaration of Conformity

The DoC is issued under the sole responsibility of the manufacturer. Under Article 15 it must follow the Annex IV model structure, include the Module A elements, and be continuously updated.

For products sold in multiple Member States, plan the translation workflow in the same way you plan instruction translation.

  • List the product clearly enough to link it to the technical file and the traceability identifiers on the product.
  • List all applicable Union harmonisation legislation, not only LVD.
  • Use the same standards references and versions that appear in the standards register and technical file.
  • Control signatory authority, version history, and translated versions.
Section 5

5) CE marking, traceability, and accompanying information

Market surveillance often starts with surface compliance: CE marking, manufacturer and importer details, and instruction language. These are also the easiest issues to prevent.

The directive is precise about what must accompany the product and what must merely be held available.

  • Affix CE visibly, legibly, and indelibly to the product or data plate, or to packaging and documents where the product nature does not allow it.
  • Mark the product with type, batch, serial number, or another element that clearly links the unit to the evidence set.
  • Provide manufacturer and importer names and postal addresses with a single contact point.
  • Remember that the documents that must accompany the product for importer and distributor checks are the instructions and safety information, not the full technical file.
Section 6

6) Online sales and EU based economic operator coverage

Distance selling does not relax product obligations. If the offer targets EU end users, the product is deemed made available on the Union market.

For products covered by Article 4 of Regulation (EU) 2019/1020, someone established in the EU must perform the required market surveillance support tasks.

  • Identify whether the role is carried by the EU manufacturer, importer, authorised representative, or fulfilment service provider.
  • Ensure the designated operator can keep the DoC available for the required period and ensure technical documentation can be produced on request.
  • Keep a response pack ready for online platform issues, customs questions, and authority requests.
Primary sources

References and citations

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