ChecklistEU

EU LVD 2014/35/EU Checklist

A CE marking readiness checklist you can run before release.

Each item should have an owner, evidence link, and acceptance criteria.

Back to main artifact Review sources

Author

Sorena AI

Published

Feb 21, 2026

Updated

Feb 21, 2026

Sections

Structured answer sets in this page tree.

Primary sources

Cited legal and guidance references.

Publication metadata

Sorena AI

Published Feb 21, 2026

Updated Feb 21, 2026

Overview

This checklist is designed to survive two real tests: an internal release gate for shipping CE marked products and a market surveillance request for documentation. Use it per product family, link every item to evidence in your technical documentation index, and make sure importer and distributor touchpoints are covered as well as manufacturer tasks.

Section 1

A) Scope and applicability (don't build the wrong evidence pack)

Scope is the highest leverage step. Document it once and reuse it across variants.

Rated voltage, power architecture, and finished product versus component status documented.
Annex II exclusions explicitly checked and recorded in a scope memo.
Applicable Union legislation list created, including LVD, EMC, RED, machinery, and other relevant acts where applicable.
Economic operator roles confirmed, including any Article 4 responsible economic operator for distance sales.
Type, batch, serial number, or other traceability identifier linked clearly to the technical documentation set.

Section 2

B) Safety objectives and risk assessment (Annex I -> hazards -> controls)

Evidence must show how Annex I safety objectives are met - not just that tests were run.

Hazard log created (including non-electrical hazards caused by the equipment).
Environment assumptions documented (installation, humidity, overload, misuse).
Controls mapped to hazards (design features + protective measures).
Verification methods defined per hazard (tests, calculations, inspections).
Residual risks documented with warnings/instructions where needed.

Section 3

C) Standards governance (presumption of conformity done right)

Standards are controls. Track versions, scope, and partial application.

Standards register per product family with decision reference, edition, hazards covered, and cessation date where relevant.
Clause mapping for partial application with justified exclusions and alternative controls.
Standards update review cadence defined around OJ decisions, including 2024 and 2025 amendments where relevant to the product.
Alternative technical solutions documented where harmonised standards are not used or are used only in part.

Section 4

D) Verification testing and engineering evidence

Test evidence should be reproducible: configurations tested, limits, and results.

Test plan references hazards and standards clauses; includes abnormal/fault conditions where relevant.
Test reports available and linked (dielectric strength, leakage current, temperature rise, mechanical, etc. as applicable).
Critical components list maintained (safety-related parts, insulation system, protective devices).
Manufacturing controls documented for safety-critical steps (QA checks, calibration, process limits).

Section 5

E) Technical documentation (Annex III) and retention

Your technical file index is the map. Without it, you can't respond fast.

Annex III technical documentation complete, including product description, drawings, explanations, risk analysis, standards list, calculations, and test reports where applicable.
Evidence pack export created with stable filenames and a response pack that can be shared quickly with authorities.
Technical file owner, storage location, retrieval SLA, and 10 year retention process defined.
Importer document holding requirement covered: copy of the DoC retained for 10 years and technical documentation availability contractually secured.

Section 6

F) EU Declaration of Conformity (DoC) + CE marking + traceability

These are the first things checked. Treat them as release blockers if wrong.

DoC drafted in Annex IV model structure, lists all applicable legislation, and is continuously updated when product or standards references change.
CE marking affixed correctly and consistently across product, data plate, packaging, and accompanying documents where needed.
Manufacturer and importer traceability details present with a single contact point and legible postal address.
Where applicable, Article 4 economic operator details for the EU market are indicated on the product, packaging, parcel, or accompanying document.

Section 7

G) Instructions and safety information (language + clarity)

Instruction quality is compliance quality. It must align to hazards and be understandable.

Instructions and safety information align to the hazard analysis and foreseeable misuse assumptions.
Language set for each target Member State is defined and translation ownership is contractually assigned.
Warnings, installation limits, maintenance conditions, and overload limitations are clear and intelligible.
Importer and distributor pre sale checks confirm that the required instructions and safety information are actually present.

Section 8

H) Post-market and market surveillance readiness

Plan for enforcement before it happens: corrective actions, complaints, and rapid evidence retrieval.

Complaint, non conformity, and recall register maintained with named owners and escalation criteria.
Corrective action workflow defined for Article 19 risk cases, Article 21 compliant but risky products, and Article 22 formal non compliance findings.
Market surveillance response pack maintained with DoC, technical documentation index, key test reports, and contact point.
Supply chain traceability information retained for 10 years so affected units can be isolated during corrective action.

Recommended next step

Turn EU LVD 2014/35/EU Checklist into an operational assessment

Assessment Autopilot can take EU LVD 2014/35/EU Checklist from turning this checklist into an operational workflow to a reusable workflow inside Sorena. Teams working on EU LVD 2014/35/EU can keep owners, evidence, and next steps aligned without copying this guide into separate documents.

Assessment workflow

Open Assessment Autopilot for EU LVD 2014/35/EU Checklist

Start from EU LVD 2014/35/EU Checklist and turn the guidance into owned tasks, evidence requests, and review checkpoints.

Explore next step

Talk to Sorena

Talk through EU LVD 2014/35/EU

Review your current process, evidence gaps, and next steps for EU LVD 2014/35/EU Checklist.

Explore next step

Primary sources