What must a CE technical documentation file contain?

A general description of the product, design and manufacturing drawings or schematics, descriptions and explanations needed to understand those drawings, the list of harmonised standards applied (in full or in part), the results of design calculations and the risk assessment, test reports from accredited laboratories, the EU Declaration of Conformity, and the user instructions. The exact list is set by Annex II of Decision 768/2008/EC and refined by each applicable directive.

How long must the technical file be kept?

For most New Approach directives (EMC, LVD, RED, RoHS, Machinery) the manufacturer or the authorised representative must keep the technical file and the EU Declaration of Conformity for ten years after the last unit of the product has been placed on the market. Some sectors set longer periods, for example fifteen years for implantable medical devices under the MDR.

Who has to keep the technical file?

The manufacturer keeps it, or the authorised representative established in the EU when the manufacturer has appointed one in writing. Importers must be able to obtain a copy on request and must indicate where the file is held. The file does not have to be filed with any authority in the EU, it is held by the economic operator and produced on demand.

Who can ask to see the technical file?

National market surveillance authorities. They can require the manufacturer, the authorised representative or the importer to hand over the file, in a language they can understand, within a reasonable period. There is no public filing, the file stays confidential and is disclosed only to the competent authority on a reasoned request.

Is the technical file the same as the Declaration of Conformity?

No. The Declaration of Conformity is a one to two page signed legal statement that the product meets every applicable directive. The technical file is the full body of evidence behind that statement. The DoC is itself one of the documents kept inside, or alongside, the technical file. One is the claim, the other is the proof.

Does the EU technical file work for FCC or UKCA?

No, but the underlying evidence is reusable. The US FCC system is built on exhibits filed electronically with the equipment authorization application, not a held file. UKCA mirrors the EU technical file concept almost exactly, so the same dossier structure transfers with the standards references updated to the UK designated list.

Does the technical file need to be in English?

Not necessarily. The file is kept in a language chosen by the manufacturer, but a market surveillance authority can request it in a language it readily understands, which in practice means the official language of the member state where the product is sold. The EU Declaration of Conformity must be translated into the languages required by each member state of sale.

Technical documentation file: required contents

Author Hugues Orgitello Last updated 28 May 2026 ~12 min read

Guide · The technical documentation file

The technical documentation file, also called the technical file or technical construction file, is the single most important document set behind any CE marking. The marking on the product and the signature on the Declaration of Conformity are only the visible tip. Underneath sits a structured body of evidence that proves the product actually meets every applicable directive. This page is the unified, cross-cutting reference for that file: what it must contain, how to structure it, how long to keep it, who may demand it, and how the same evidence is repackaged for the US and UK markets. Each pillar on this site has its own technical-file page, this one consolidates the common rules.

What the technical file is, and why it matters

The technical file is the legal backbone of CE marking. When a manufacturer affixes the CE marking and signs the EU Declaration of Conformity, it is making a binding legal claim that the product satisfies the essential requirements of every applicable directive. The technical file is the proof of that claim. Without it, the marking is unsupported and the product is, in legal terms, non-compliant even if it would have passed every test.

The principle is set out generically in Decision 768/2008/EC, the reference decision that defines the common framework for marketing products in the EU. Annex II of that decision lists the elements the technical documentation must contain. Each vertical directive then refines that list in its own annex: Annex II of the Directive 2014/30/EU (EMC), Annex V of the Directive 2014/53/EU (RED), Annex VII of the Directive 2006/42/EC (Machinery), and so on. The directives differ in detail, but the spine is the same everywhere.

Three things follow from this. First, the file is not optional paperwork produced after the fact, it is the documented reasoning that led to the marking decision. Second, it must allow a competent third party to assess conformity without re-doing the design, which means it has to be complete enough to stand alone. Third, it is the document the authorities will ask for first when they check a product on the market.

The required contents

Annex II of Decision 768/2008/EC requires the technical documentation to make the assessment of conformity possible. In practice that resolves to the following building blocks. The table below maps each element to its purpose.

Element	What it is	Why it is required
General product description	Identification, intended use, variants, models, photos	Lets the authority know exactly what is being assessed
Design drawings and schematics	Mechanical drawings, electrical and PCB schematics, block diagrams	Shows how the product is built
Descriptions and explanations	Notes that make the drawings understandable	Ensures the drawings can be interpreted
List of harmonised standards	Standards applied in full or in part, with versions	Establishes the presumption of conformity
Design calculations and risk assessment	Calculations, risk analysis, results	Demonstrates the essential requirements are met
Test reports	Reports from accredited laboratories	Objective evidence of compliance
EU Declaration of Conformity	The signed statement of conformity	Links the file to the legal claim
User instructions and safety information	Manuals, warnings, installation notes	Required by most directives as part of conformity
Software and firmware identification	Versions, build identifiers where relevant	Pins the file to a specific tested configuration

General product description

Every file opens with an unambiguous identification of the product: commercial name, type, model and serial or batch numbering scheme, intended use, the range of variants covered, and photographs. This section answers the question a market surveillance officer asks first, which product, exactly, is this file about. Where a single file covers a family of products, the description must make the boundaries of the family explicit.

Design and manufacturing drawings

The file must contain the drawings and schematics that show how the product is designed and built: mechanical assembly drawings, electrical schematics, PCB layouts, block diagrams, and the bill of materials where safety-relevant components are involved. Annex II requires not just the drawings but the descriptions and explanations necessary to understand them. A schematic that cannot be read without the designer present does not satisfy the requirement.

List of harmonised standards applied

This is the link between the product and the legal presumption of conformity. The file lists each harmonised standard applied, with its exact reference and version, and states whether it was applied in full or only in part. Where a standard is applied in part, or where no harmonised standard exists for a given essential requirement, the file must describe the other solution adopted to meet the requirement. Citing a standard withdrawn from the Official Journal no longer confers presumption of conformity, so the versions matter.

Risk assessment

Most directives require a documented risk assessment. For general safety this is the analysis under the LVD and the Machinery Directive, for radio it is the article 3.1(a) safety and 3.2 spectrum analysis, for medical devices it is the full ISO 14971 risk management file. The assessment identifies hazards, estimates risks, records the protective measures taken, and shows the residual risk is acceptable. It is the reasoning that justifies the design choices, not a checklist appended at the end.

Test reports from accredited laboratories

Objective evidence comes from test reports. Reports issued by a laboratory accredited to ISO/IEC 17025 carry the most weight, and for some routes are effectively required. Reports must identify the exact sample tested, the standards and clauses applied, the measurement uncertainty, and the verdict per clause. Where the manufacturer relies on a pre-certified radio module, the integration tests it ran on the finished product belong in the file too, the module certificate alone is not enough.

The EU Declaration of Conformity

The signed EU Declaration of Conformity is itself part of the documentation kept by the manufacturer. It lists every directive applied, the standards relied upon, the identity and signature of the responsible person, and the date and place of issue. The relationship is hierarchical: the DoC is the public-facing claim, the technical file is the private evidence behind it.

User instructions and safety information

For most directives the user instructions are not an afterthought, they are part of the conformity. Missing or inadequate warnings, missing installation instructions, or instructions not provided in the required language are themselves non-conformities. The file keeps the as-published instructions for every market.

Software and firmware versions

For connected and software-driven products, the file must pin down the exact software and firmware versions that were tested and assessed. A firmware update that changes radio behaviour, safety logic or cybersecurity posture can move the product outside the assessed configuration. Recording build identifiers lets the manufacturer and the authority tie a field unit back to the file.

How to structure the file

There is no mandated layout, only a mandated content. A clear, indexed structure makes the file usable for the people who will read it under pressure: an auditor, a Notified Body reviewer, or a market surveillance officer with a deadline. A robust structure follows the order of the contents above.

Section	Folder	Typical documents
0	Index and revision history	Table of contents, document control, change log
1	Product identification	Description, models, intended use, photos, labels
2	Applicable directives	Directive mapping, classification rationale
3	Standards applied	List with versions, full or partial application
4	Design documentation	Drawings, schematics, PCB, BoM, explanations
5	Risk assessment	Hazard analysis, calculations, residual risk
6	Test reports	Accredited lab reports per directive
7	User documentation	Manuals, warnings, installation, languages
8	Software and firmware	Versions, build IDs, update policy
9	Declaration of Conformity	Signed DoC, supporting attestations

Keep a single index at the front and a revision history. When the product changes, the file changes with it, and the change log is what lets you prove which version of the file supported which production batch. See the CE technical file pillar page for the CE-specific layout and the CE overview for where the file sits in the wider process.

Retention: how long, and who keeps it

For the great majority of New Approach directives, the rule is identical: the technical file and the EU Declaration of Conformity must be kept for ten years after the last unit of the product has been placed on the market. The ten years run from the last unit, not from the first, so a long-lived product extends the obligation well past the end of production.

Directive or regulation	Retention period	From
Directive 2014/30/EU (EMC)	10 years	Last unit placed on the market
Directive 2014/35/EU (LVD)	10 years	Last unit placed on the market
Directive 2014/53/EU (RED)	10 years	Product placed on the market
Directive 2011/65/EU (RoHS)	10 years	Product placed on the market
Directive 2006/42/EC (Machinery)	10 years	Date of manufacture (last unit of the series)
Regulation 2017/745 (MDR)	10 years, 15 for implantables	Last device placed on the market

The holder of the file is the manufacturer, or the authorised representative established in the EU if the manufacturer has appointed one by written mandate. The mandate must explicitly cover keeping the file at the disposal of the authorities. Importers do not have to hold the file themselves but must be able to provide a copy on request and must know where it is kept. The file is not filed with any EU authority, it is held by the economic operator and produced on demand.

Who can request it, and in what language

The audience for the technical file is narrow and official. National market surveillance authorities, acting under Regulation (EU) 2019/1020, can require the manufacturer, the authorised representative or the importer to provide the file. The request is reasoned, and the file must be supplied within a reasonable period in a language the authority readily understands.

In practice that means the official language of the member state where the product is sold, or another language agreed with the authority. The file does not have to be pre-translated into every EU language, only produced in a language the requesting authority can read. The narrower availability rule contrasts with the EU Declaration of Conformity, which must be translated into the language or languages required by each member state where the product is made available.

The file stays confidential. There is no public register, and the authority is bound to protect commercially sensitive information. This is a deliberate balance: the evidence is available to those who police the market, but not to competitors.

The technical file versus the Declaration of Conformity

These two are routinely confused. They are different objects with different roles.

Aspect	Technical file	EU Declaration of Conformity
Nature	Body of evidence	Signed legal statement
Length	Tens to hundreds of pages	One to two pages
Audience	Authorities, on request	Public, accompanies the product
Content	Drawings, tests, risk analysis	List of directives and standards
Translation	On request, per authority	Into the languages of each market
Relationship	Contains or references the DoC	Summarises and points to the file

The simplest way to hold the distinction: the DoC is the claim, the technical file is the proof. The DoC is one short document that lives inside, or alongside, the much larger file. A complete DoC with no file behind it is a hollow claim, a complete file with no signed DoC is missing its legal conclusion. You need both.

How it differs: EU, US FCC, and UKCA

The same engineering evidence has to be packaged differently for the three major markets. The underlying test data is largely reusable, the container and the rules around it are not.

Aspect	EU (technical file)	US (FCC exhibits)	UK (UKCA technical file)
Form	Held file, produced on request	Exhibits filed electronically	Held file, produced on request
Where it lives	With the manufacturer or rep	In the FCC application record	With the manufacturer or UK rep
Filed with authority?	No	Yes, with the application	No
Trigger	Market surveillance request	Authorization application	Market surveillance request
Standards basis	Harmonised standards (OJEU)	FCC rules in 47 CFR	UK designated standards
Identifier	None centralised	FCC ID issued	None centralised

In the EU the file is kept by the economic operator and only shown when an authority asks. In the US the model is filing-based: for certified equipment, a set of exhibits (test report, internal and external photos, block diagram, schematics, operational description, user manual, labelling) is uploaded with the equipment authorization application and reviewed by a Telecommunication Certification Body before a grant and an FCC ID are issued. The evidence is similar, but it is submitted up front and becomes part of an application record rather than a held file.

UKCA mirrors the EU model almost exactly. The technical file concept, the contents, the ten-year retention and the held-on-request availability all carry over. The practical work is updating the standards references from the EU Official Journal harmonised list to the UK designated standards list, and naming a UK-based responsible person where required. For a product already CE marked, building the UKCA file is mostly a remapping exercise on the same evidence base, which is why the self-declaration versus Notified Body decision often carries across both markets.

Common pitfalls

A file that exists is not the same as a file that holds up. The recurring failures fall into a short list.

Standards cited but not actually applied. The list names a harmonised standard, but the test reports do not cover all its clauses, or cite a withdrawn version. This breaks the presumption of conformity, see the harmonised standards guide.
No risk assessment, or a generic one. A template risk analysis not tailored to the product is a frequent finding. The assessment must reason about the actual hazards of the actual product.
Module conformity inherited without integration tests. Relying on a pre-certified radio module without documenting the integration tests on the finished product. The certificate covers the module, not the host.
Drawings without explanations. Schematics and PCB layouts dumped in without the descriptions Annex II requires to make them understandable.
Firmware version not pinned. The tested build is not recorded, so a later update silently moves the product outside the assessed configuration.
File not maintained. The product is revised but the file is frozen at the first release, with no change log tying file versions to production batches.
Availability not arranged. The manufacturer is outside the EU, no authorised representative holds the file, and the importer cannot say where it is. A structural non-compliance independent of the product's technical quality.

A checklist table of contents

Use this as the index page at the front of the file. Every line should resolve to a document or a deliberate, recorded "not applicable".

#	Item	Present
1	General product description, models, intended use	yes / no
2	Identification and labelling (CE marking, ratings, warnings)	yes / no
3	List of applicable directives and classification rationale	yes / no
4	List of harmonised standards applied, with versions	yes / no
5	Design drawings, schematics, PCB layouts, block diagrams	yes / no
6	Descriptions and explanations of the drawings	yes / no
7	Bill of materials for safety-relevant components	yes / no
8	Design calculations	yes / no
9	Risk assessment and residual-risk justification	yes / no
10	Test reports from accredited laboratories, per directive	yes / no
11	Integration test evidence for any certified modules used	yes / no
12	Software and firmware versions and build identifiers	yes / no
13	User instructions and safety information, per language	yes / no
14	EU Declaration of Conformity, signed and dated	yes / no
15	Authorised representative mandate, if applicable	yes / no
16	Revision history and document control	yes / no

A file that answers "yes" to every applicable line, with a recorded reason for each "no", is a file that will survive an audit. The discipline of maintaining it from the start of design, rather than assembling it the week before launch, is what separates a compliant product from a marking that cannot be defended.