RequirementsEU

EU LVD 2014/35/EU Requirements

A clear duties map across the supply chain.

Focus: manufacturers, importers, distributors - and the evidence each must be able to produce.

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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

LVD compliance is operational: who must do what, which artifacts must exist, and how quickly those artifacts can be produced when the product is placed on the EU market and throughout its lifecycle. This page turns Directive 2014/35/EU, the 2018 LVD Guide, and Regulation (EU) 2019/1020 into a requirements to evidence map you can apply per product family.

Section 1

1) The three anchors of LVD compliance

Most duties under the directive cluster around three anchors: meeting Annex I safety objectives, maintaining the Annex III evidence set, and controlling market placement through the DoC, CE marking, traceability, and instructions.

When a program is weak, one of these anchors is usually unowned.

  • Annex I safety objectives and risk based design evidence.
  • Annex III technical documentation and 10 year retention.
  • DoC, CE marking, traceability, accompanying information, and corrective action readiness.
Section 2

2) Manufacturer obligations

Manufacturers carry the primary burden under Article 6. They design and manufacture to the Annex I objectives, carry out Module A, draw up the technical file, issue the DoC, and affix CE marking.

They also have to maintain conformity in series production, not just at prototype stage.

  • Design and manufacture in accordance with Article 3 and Annex I.
  • Draw up Annex III technical documentation, including adequate risk analysis and assessment.
  • Keep the technical documentation and DoC for 10 years after placement on the market.
  • Ensure type, batch, serial, manufacturer contact details, instructions, and safety information are correct and present.
Section 3

3) Authorised representative, importer, and distributor obligations

The rest of the supply chain has real duties, not just commercial roles. The LVD Guide is especially useful on what importers and distributors must actually verify and hold.

This is where many product teams under document their operating model.

  • Authorised representatives can be mandated to keep the DoC and technical file at the disposal of authorities for 10 years and to cooperate on corrective action.
  • Importers place only compliant products on the market, keep a copy of the DoC for 10 years, and ensure technical documentation can be obtained on request.
  • Distributors verify CE marking, manufacturer and importer details, and required instructions and safety information before making the product available.
  • Importers and distributors must not place or make available products they know or should know are non compliant.
Section 4

4) Instructions, languages, and traceability

Instruction and language duties are not cosmetic. They are part of the safety solution and are checked early in enforcement.

Traceability duties determine how efficiently you can isolate affected products during corrective action.

  • Instructions and safety information must be in a language easily understood by consumers and other end users, as determined by the Member State concerned.
  • Manufacturer and importer postal addresses must identify a single contact point and be understandable to end users and market surveillance authorities.
  • Type, batch, serial number, or equivalent identifier must link the individual product to the evidence set.
  • Supply chain counterparties must remain identifiable for 10 years before and after supply.
Section 5

5) Responsible economic operator coverage for EU sales

Regulation (EU) 2019/1020 adds an extra operating layer for products within Article 4 scope. For many distance sold products, you need an EU based operator who can support market surveillance requests.

This requirement should be solved in the business model, not left for later legal cleanup.

  • Confirm 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 and ensure technical documentation can be made available on request.
  • Display the required operator details on the product, packaging, parcel, or accompanying document where the legislation requires it.
Section 6

6) Evidence mapping: requirement to artifact to owner

The compliance accelerator is a requirements map that links each obligation to an artifact and an owner. That removes ambiguity and keeps changes reviewable.

Use it as the backbone of the release gate and the response pack.

  • Annex I objective -> hazard log -> design control -> test report owner.
  • Annex III documentation -> indexed file set -> technical file owner.
  • DoC and CE marking -> release gate checklist -> compliance or regulatory owner.
  • Complaints, CAPA, withdrawals, and recalls -> post market workflow owner.
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Primary sources

References and citations

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