CE marking is supported by evidence. The technical documentation — commonly referred to as the technical file — is where that evidence is brought together to demonstrate how a product satisfies the applicable requirements of European Union product legislation.
A CE mark on a product and an EU Declaration of Conformity are visible outputs of a much larger conformity-assessment process. Behind them should exist an organised body of engineering, regulatory and technical evidence capable of demonstrating why the manufacturer concluded that the product conforms.
Technical documentation is therefore not simply a collection of certificates and laboratory reports. It should explain the product, identify the applicable legislation, document its design and manufacture, establish the applicable requirements, assess relevant risks and show how conformity has been demonstrated.
For complex products, this can involve drawings, calculations, component specifications, bills of materials, risk assessments, harmonised standards, test reports, software information, manufacturing controls, instructions, labels, Notified Body documentation and the EU Declaration of Conformity.
The exact documentation required depends on the applicable Union harmonisation legislation and the nature of the product. A machinery technical file will not necessarily have the same contents as the documentation required for radio equipment, pressure equipment, electrical equipment or personal protective equipment.
This GAR Insight explains how manufacturers can structure CE marking technical documentation, what evidence commonly belongs in the technical file, how risk assessments and standards should connect to test evidence, and how to maintain a file capable of supporting conformity throughout the product lifecycle.
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Explore the structure, contents, evidence, control and maintenance of CE marking technical documentation.
What Is CE Marking Technical Documentation?
Technical documentation is the body of information prepared and maintained to demonstrate that a product complies with the applicable requirements of Union harmonisation legislation.
The expression “technical file” is widely used in industry, although the terminology and exact requirements can vary between different pieces of EU legislation.
The documentation should allow the conformity of the product to be assessed. It should therefore describe the product, its design, manufacture and operation, and contain the evidence necessary to demonstrate compliance with the applicable legal requirements.
Why Is Technical Documentation Required?
CE marking represents the manufacturer’s conclusion that the product fulfils the applicable requirements. Technical documentation provides the evidence supporting that conclusion.
It also enables competent authorities to evaluate how conformity was established if questions arise after the product has been placed on the market.
Demonstrate Conformity
Provide evidence showing how applicable legal requirements have been satisfied.
Support the EU DoC
Provide the technical basis for the manufacturer’s Declaration of Conformity.
Support CE Marking
Demonstrate why the manufacturer was entitled to affix CE marking.
Support Market Surveillance
Enable competent authorities to assess conformity when documentation is requested.
Start With an Unambiguous Product Description
Before conformity can be demonstrated, the technical file must make clear exactly which product has been assessed.
Product identification should correspond with the drawings, labels, test samples, instructions and EU Declaration of Conformity.
Product Name
Identify the commercial and technical designation of the product.
Model / Type
Identify the exact model, type, series or product family.
Variants
Define which variants are covered and how their differences affect conformity.
Intended Use
Describe the purpose for which the product is designed and supplied.
Operating Environment
Identify relevant industrial, domestic, outdoor, hazardous or other operating conditions.
Technical Characteristics
Record relevant ratings, capacities, dimensions, power sources and performance characteristics.
Document the Applicable EU Legislation
The technical file should record which Union harmonisation legislation applies to the product and provide a defensible basis for that determination.
For multifunctional equipment, several Directives or Regulations may apply simultaneously.
| Assessment Area | Technical File Record | Purpose |
|---|---|---|
| Product Classification | Product type, functions and intended use | Establish regulatory scope |
| Applicable Legislation | Relevant EU Directives and Regulations | Define legal requirements |
| Scope Assessment | Applicability, exclusions and interfaces | Support regulatory decisions |
| Essential Requirements | Applicable safety and performance requirements | Define conformity criteria |
| Conformity Route | Applicable assessment procedure or module | Establish required assessment |
| Standards | Harmonised and other technical standards | Document technical assessment route |
Design, Drawings, Calculations & Specifications
The technical documentation should contain sufficient engineering information to understand the product’s design, manufacture and operation.
General Arrangement Drawings
Show the overall product architecture, principal assemblies and relevant physical configuration.
Detailed Drawings
Document safety-critical parts, dimensions, materials and interfaces where relevant.
Circuit Diagrams
Record electrical, control and electronic architecture as applicable.
Design Calculations
Maintain calculations supporting structural, pressure, thermal, electrical or other design decisions.
Specifications
Record materials, ratings, tolerances and performance requirements.
Functional Description
Explain how the product and its safety-related systems operate.
The Risk Assessment — Connecting Hazards to Design
Where risk assessment is required by the applicable legislation, it forms a critical part of the technical documentation. It demonstrates that hazards have been identified systematically and addressed through appropriate design and protective measures.
Define Limits
Establish intended use, foreseeable conditions and relevant product boundaries.
Identify Hazards
Identify mechanical, electrical, thermal and other applicable hazards.
Estimate Risk
Evaluate the nature and significance of identified risks.
Reduce Risk
Apply appropriate design and protective measures.
Verify Measures
Confirm that protective measures perform as intended.
Residual Risks
Identify residual risks requiring information or warnings.
Document Evidence
Link conclusions to drawings, tests and technical controls.
Maintain Review
Reassess risks when relevant product changes occur.
Document Harmonised Standards & Technical Specifications
The technical documentation should identify the standards and other technical specifications used to demonstrate conformity with applicable requirements.
Where harmonised standards are relied upon for presumption of conformity, the manufacturer should ensure that the standards used correspond with the applicable legislation, product scope and technical evidence.
Standard Reference
Record the complete designation of the standard used.
Edition / Amendment
Maintain the edition and amendments forming the basis of assessment.
Applicable Clauses
Identify relevant clauses where useful for demonstrating compliance.
Deviations
Record justified deviations, alternative technical solutions or partially applied standards where relevant.
Test Reports, Inspection Records & Technical Evidence
Testing and verification records provide objective evidence that particular safety, performance or regulatory requirements have been evaluated.
Electrical Safety
Electrical shock, insulation, temperature, abnormal operation and related safety evidence where applicable.
EMC
Emissions and immunity testing relevant to electromagnetic compatibility.
Radio
Radio spectrum and other applicable RED-related technical evidence.
Mechanical
Strength, stability, guarding, functional safety or other mechanical verification.
Pressure
Material, welding, NDT, pressure test and other integrity evidence where applicable.
Environmental
Substance, energy-performance or environmental testing where applicable.
Components, Materials & Supplier Documentation
Product conformity frequently depends on components and materials obtained from external suppliers. Relevant supplier documentation can therefore form an important part of the technical file.
Component Specifications
Maintain specifications for safety-critical or compliance-relevant components.
Material Certificates
Retain material evidence where composition or properties affect conformity.
Supplier Declarations
Maintain relevant declarations supporting regulatory or material requirements.
Component Certificates
Retain certificates and approvals relevant to the final product assessment.
From Approved Design to Consistent Manufacturing
Conformity is not limited to a prototype submitted for testing. Products manufactured and placed on the market must remain consistent with the design and configuration for which conformity was established.
Bill of Materials
Control components and materials that influence product conformity.
Manufacturing Specifications
Define production characteristics necessary to maintain the compliant design.
Inspection & Testing
Maintain appropriate production inspection and verification records.
Change Control
Evaluate design, component and process changes for their effect on conformity.
Instructions, Labels, Warnings & Product Marking
Information supplied with or displayed on the product forms part of the overall conformity framework. The technical file should therefore contain the controlled versions of relevant instructions, labels, markings and safety information.
Instructions
Installation, operation, maintenance and other required instructions.
Warnings
Safety information addressing relevant residual risks and limitations.
Rating Plate
Manufacturer, model and technical information required on the product.
CE Marking
Evidence of the intended CE marking format and placement.
Product Identifiers
Model, type, batch, serial or other required traceability information.
Translations
Controlled language versions required for relevant EU markets.
Notified Body Certificates & Assessment Records
Where applicable legislation requires involvement of a Notified Body, the resulting certificates and conformity-assessment records form an important part of the technical documentation.
Notified Body Identity
Record the correct organisation and identification number relevant to the assessment.
Assessment Procedure
Document the conformity-assessment module or procedure performed.
Certificates
Retain applicable EU-type examination or other required certificates.
Supporting Reports
Maintain assessment, audit or technical reports relevant to the conformity route.
Retention, Revision Control & Product Changes
Technical documentation should remain controlled throughout the period required by the applicable Union harmonisation legislation and should accurately represent the product placed on the market.
Retention Period
Determine and comply with the retention period established by the applicable legislation.
Revision Control
Identify current and superseded versions of important technical records.
Product Changes
Evaluate whether modifications require new risk assessment, testing or conformity assessment.
Standards Changes
Monitor relevant changes to standards and assess their impact on the conformity basis.
Regulatory Changes
Review new or amended EU requirements affecting products being placed on the market.
Authority Requests
Maintain the documentation so that required information can be supplied to competent authorities.
Building a Defensible CE Compliance Record
A well-structured technical file should allow a competent technical reviewer to follow the conformity logic from product definition through engineering assessment to the final Declaration of Conformity.
Define Product
Identify the exact product, models, variants and intended use.
Map Legislation
Identify applicable EU Directives and Regulations.
Map Requirements
Establish applicable essential and other legal requirements.
Assess Risks
Identify hazards and document risk-reduction measures.
Select Standards
Establish the technical standards supporting conformity.
Document Design
Assemble drawings, specifications and engineering calculations.
Verify Product
Conduct required testing, inspection and technical assessment.
Control Components
Maintain relevant material and supplier conformity evidence.
Control Production
Ensure manufactured products remain consistent with assessed design.
Control User Information
Finalise instructions, warnings, labels and product marking.
Complete Technical File
Consolidate and review the complete conformity evidence.
Issue EU DoC
Declare conformity based on the completed technical evidence.
The Technical File Is the Evidence Behind the CE Mark
CE marking is visible on the product. The EU Declaration of Conformity records the manufacturer’s formal conclusion. The technical documentation provides the evidence explaining why that conclusion was reached.
A strong technical file therefore does more than collect documents. It creates traceability between the product, applicable EU legislation, essential requirements, identified risks, engineering solutions, harmonised standards, conformity-assessment procedures and verification evidence.
This distinction becomes especially important for complex products. A machine containing electrical systems, radio communication, pressure equipment and electronic controls may generate evidence from several engineering disciplines and several conformity-assessment activities. Those records should ultimately describe one finished product and one coherent conformity strategy.
The same principle applies to supplier documentation. Certificates for motors, power supplies, radio modules, safety components or materials may support the manufacturer’s assessment, but they do not replace the evaluation of the integrated finished product.
Technical documentation should also remain alive throughout the product lifecycle. Design modifications, component substitutions, firmware changes, revised standards and regulatory developments may require reassessment and corresponding updates to the conformity evidence.
The Evidence Question
Can every applicable legal and technical requirement be traced to engineering documentation, risk controls, testing or other objective evidence demonstrating how conformity was achieved?
The Configuration Question
Does the technical file describe and support the exact product configuration, components, software, instructions and marking that are actually being placed on the European market?