Technical FileEU

EU LVD 2014/35/EU Technical Documentation

A technical file structure you can hand to market surveillance in minutes.

Focus: Annex III checklist + evidence indexing + retention and change control.

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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

Under the LVD, technical documentation is the core conformity artifact. Annex III is explicit that the file must make it possible to assess conformity and include an adequate analysis and assessment of risks. A good file is therefore not a dump of PDFs. It is a navigable evidence system that connects Annex I objectives, standards choices, tests, and released product configurations.

Section 1

1) What the technical documentation must achieve

A reviewer should be able to move quickly from product identity to hazard reasoning to evidence. If that path is not obvious, the file is incomplete even if the documents technically exist.

Think of the technical file as the source of truth that supports the DoC, CE marking, importer support, and corrective action.

Clear product identity, variants, photos, labels, and traceability logic.
Explicit connection from Annex I objective to hazard, control, test method, and result.
A change history that explains why the current DoC is still valid.

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Section 2

2) Annex III minimum contents

Annex III gives you the minimum schema for the file. Use it as the index, then attach additional documents where needed.

Do not forget the risk analysis requirement hidden in the opening sentence of Annex III.

General description of the electrical equipment.
Design and manufacturing drawings, schemes of components, sub assemblies, circuits, and explanations needed to understand them.
Standards list showing what was applied in full or in part, plus alternative solutions where needed.
Results of design calculations, examinations, and test reports, supported by an adequate analysis and assessment of risks.

Section 3

3) Standards and presumption of conformity inside the file

The standards register inside the technical file should show the decision references, editions, and whether a standard is fully applied, partially applied, or only used as supporting material.

This is the part of the file most likely to go stale after a product update.

Record the OJ or implementing decision context used for the standards set.
Add clause mapping for partial application and explain any gaps.
Keep update review memos for standards restrictions, withdrawals, or deferred withdrawal dates.

Section 4

4) Risk analysis should be the navigation layer

Risk analysis should not sit alone as a static spreadsheet. It should point the reviewer to the exact evidence item that closes each hazard.

This is especially important where no harmonised standard exists or where standards are applied only in part.

Link each hazard to the design control, the verification method, and the evidence ID.
Capture foreseeable misuse and external influence assumptions, not only intended use.
Show where residual risk is accepted and how warnings or instructions address it.

Section 5

5) Holding, retention, and availability rules

Manufacturers keep the technical file and the DoC for 10 years after placement on the market. Importers must ensure the file can be made available on request, and an authorised representative can be mandated to hold it at the disposal of authorities.

That means file ownership, storage, backup, and retrieval speed are compliance controls.

Assign one technical file owner and one backup owner per product family.
Keep a response pack export with the DoC, index, scope memo, and key reports.
Document retrieval SLAs and the path for getting the file from the manufacturer to the importer or authority quickly.

Section 6