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Build and maintain your Technical File

Bring your evidence and records together in one place.

Bring your evidence and records together in one place

A Technical File is the complete body of evidence showing that a toy meets its applicable legal safety requirements.

It is not a single certificate or document. It is a collection of connected records covering the product, its risks, testing, materials, labelling and the decisions made throughout the compliance process.

For a 3D-printing business, the Technical File needs to reflect exactly what is manufactured:

  • The product as designed and printed
  • The materials and components actually used
  • The tests carried out on the finished product
  • The intended use and age grading
  • The records connecting production batches to the supporting evidence

The CertHub app is built around this structure. Instead of treating risk assessment, testing, material evidence and production records as separate jobs, it keeps them connected as one complete Technical File.

What is a Technical File for?

Under the Toys (Safety) Regulations 2011, a toy manufacturer must be able to demonstrate that a product has been properly assessed before it is placed on the market in Great Britain.

The Technical File is how that demonstration is made.

It should allow someone reviewing the product, such as a Trading Standards officer, UK Approved Body, retailer or the manufacturer at a later date, to see:

  • What the product is
  • How it was designed and constructed
  • Who it is intended for
  • Which risks were identified
  • How those risks were addressed
  • Which tests and assessments were completed
  • Which standards were applied
  • What materials and components were used
  • What evidence supports those materials
  • How the product was labelled
  • Who signed the Declaration of Conformity
  • How a production batch can be traced back to its materials and records

A Technical File is only useful if it is complete, accurate and specific to the product it covers.

A generic file is not evidence

A generic file, or one copied from a similar product without proper review, does not demonstrate that your own product has been assessed.

What belongs in the Technical File?

For an ordinary 3D-printed toy, the Technical File will normally bring together:

  • A description and identification of the product
  • Its intended use and intended age group
  • Product photographs
  • Construction details and dimensions
  • Print and assembly settings
  • The product risk assessment
  • EN71-1 mechanical and physical testing
  • The EN71-2 flammability assessment and any applicable testing
  • EN71-3 evidence for relevant accessible materials and components
  • Any additional standards or requirements relevant to the product
  • Records for filament, resin, paint, adhesives and bought-in components
  • Labelling, warnings and instructions
  • The UK Declaration of Conformity
  • Batch and production traceability
  • Changes, reviews and retesting

Each part performs a different job.

EN71-1 testing does not provide chemical evidence for the filament. An EN71-3 certificate does not prove that the finished toy is mechanically safe. A label or Declaration of Conformity cannot replace the underlying assessment.

The file only does its job when all the relevant parts are present, consistent and specific to the product being sold.

Why the pieces need to stay connected

It is common for individual pieces of evidence to exist without being clearly connected.

For example:

  • A filament certificate may not identify which products used that material.
  • A risk assessment may not match the age grading on the label.
  • Testing may relate to an earlier version of the design.
  • A component may be changed without the Technical File being reviewed.
  • A later production batch may use a different filament range.
  • A Declaration of Conformity may be signed before missing evidence is obtained.

Each individual record may look acceptable, while the complete file no longer describes the toy that was actually manufactured.

Keeping the evidence connected means:

  • The product definition matches the finished toy.
  • The risk assessment reflects the current design.
  • The testing matches the product's features and age grading.
  • Material evidence matches the exact materials used in production.
  • Labelling and warnings agree with the assessment results.
  • The Declaration of Conformity is supported by completed evidence.
  • Production batches can be traced back to the materials and records used.
  • A change to the product triggers a review of anything affected by that change.

A smaller, well-organised and internally consistent Technical File is stronger than a large collection of unrelated documents.

Building the file: the general sequence

Every product is different, but a Technical File is normally built in a logical order.

1. Define the product

Record:

  • What the product is
  • Its intended use
  • Its intended age group
  • Its dimensions
  • How it is constructed
  • The materials and components used
  • The print and assembly settings
  • Any accessories supplied with it

This creates the foundation for the rest of the assessment.

2. Assess the risks

Identify the hazards associated with the toy and how they will be controlled.

The risk assessment helps determine:

  • Appropriate age grading
  • Applicable EN71 requirements
  • Required tests
  • Materials requiring evidence
  • Necessary warnings and instructions
  • Design changes needed before sale

The testing should be informed by the risk assessment, not treated as an unrelated exercise.

3. Test the finished product

Complete and document the applicable EN71-1 mechanical and physical checks on the toy in the form in which it will be sold.

Complete the EN71-2 flammability assessment for the product and record the outcome. Where a specific physical test applies, record the method and result.

If testing reveals a problem, update the design, construction or age grading as appropriate and repeat the affected checks.

4. Gather material evidence

Collect suitable EN71-3 evidence for the relevant accessible materials and components.

The evidence should match the exact materials used, including the manufacturer, range, material type and supported colours or components.

Link each certificate or report to the relevant material record rather than storing it as an unrelated document.

5. Complete the labelling

Confirm that the product, packaging and accompanying information contain the required details, including:

  • UKCA marking
  • Manufacturer's name
  • Contact address
  • Product, batch, type, model or serial identification
  • Appropriate age grading
  • Required warnings
  • Instructions and safety information where applicable

The label must agree with the product definition, risk assessment and testing outcomes.

6. Prepare the Declaration of Conformity

The UK Declaration of Conformity is the manufacturer's formal declaration that the toy meets the applicable requirements.

It should only be signed once the supporting assessment, testing, material evidence and product information are complete and consistent.

The Declaration does not create compliance by itself. It confirms the conclusion supported by the Technical File.

7. Record production traceability

Connect each production batch to:

  • The product Technical File
  • The filament and spools used
  • Relevant materials and components
  • Production dates
  • Batch or lot identification
  • Applicable certificates
  • Any changes from the approved product specification

This allows a specific toy or batch to be traced if a material issue, complaint or safety concern arises later.

Material evidence within the file

Material evidence should identify and support the relevant accessible materials and components used in the finished toy.

It should match the exact brand, range, material and available colour coverage rather than a similar-sounding product.

The same principle applies to paints, adhesives, coatings and bought-in components that remain accessible or become accessible after testing or foreseeable damage.

The dedicated material-evidence section explains this in more detail. Within the Technical File, the important step is connecting that evidence to the materials and production records for the toy.

Keeping the Technical File current

A Technical File is not a one-off document created when a product is first launched and then forgotten.

It needs to remain accurate while the product continues to be manufactured and placed on the market.

Review the file whenever:

  • The digital model changes
  • The dimensions or scale change
  • Print orientation, walls, infill or other construction settings change
  • The intended use or age grading changes
  • A filament material or range changes
  • A new colour falls outside the available material evidence
  • An adhesive, paint or coating changes
  • A component or supplier changes
  • Testing is repeated
  • New safety information becomes available
  • Labelling, warnings or instructions change
  • A complaint or defect identifies a possible new risk
  • An applicable standard or legal requirement changes

Record the change and review any part of the file affected by it.

A change to a material may affect EN71-3 evidence. A change to the model or construction may affect EN71-1 testing. A different age grading may affect testing, warnings and the risk assessment.

Don't assume the rest of the file still holds

Do not assume that the rest of the file remains valid without checking.

How long must the records be kept?

Current government guidance requires manufacturers to retain the Technical File and Declaration of Conformity for 10 years after the toy is placed on the market.

For a product that remains in production, later toys and batches are placed on the market at later dates. The retention period must therefore be considered in relation to those later products, not only the first date on which the design was launched.

In practical terms, you should preserve the product's compliance records for at least 10 years after the last relevant toy is placed on the market.

The records must remain available and usable throughout the retention period, even if you stop selling the product or stop using the software originally used to create them.

Continued production must remain compliant

Completing a Technical File for the first sample does not remove the need to control future production.

Your ongoing records should show that later toys continue to match the assessed product.

This may include:

  • Batch records
  • Filament and spool traceability
  • Component records
  • Print settings
  • Production dates
  • Quality checks
  • Supplier changes
  • Complaints
  • Defects
  • Corrective action
  • Design changes

If production moves away from the assessed specification, review the Technical File and repeat any affected assessments or tests.

How the CertHub app helps

The CertHub app is designed to keep the different parts of a Technical File structured and connected.

It helps you:

  • Define the product and intended age group
  • Complete the product risk assessment
  • Work through the applicable EN71-1 checks
  • Record EN71-2 applicability and conclusions
  • Record materials and components
  • Upload and link EN71-3 certificates
  • Maintain a Material Register
  • Record filament spools and batch information
  • Create labelling and marking records
  • Prepare the UK Declaration of Conformity
  • Record production batches and variants
  • Maintain a change history
  • Export the completed Technical File and supporting records

The app also helps you monitor material evidence and review dates, making it easier to identify records that may need attention.

Instead of storing testing, certificates, photographs and production information as separate files that must be cross-checked manually, the app keeps them connected to the relevant product.

You remain responsible

The app organises and documents your work. You remain responsible for the product, the tests carried out, the evidence used and the final declaration of conformity.

Before you rely on your Technical File

Confirm that:

  • The product description matches what is actually manufactured.
  • The intended use and age grading are recorded.
  • The risk assessment reflects the finished product.
  • Applicable EN71-1 tests have been completed and documented.
  • The EN71-2 assessment has been completed.
  • Any applicable EN71-2 testing has been recorded.
  • Relevant accessible materials and components have suitable evidence.
  • Material evidence matches the exact products used.
  • Labelling and warnings match the assessment outcomes.
  • The Declaration of Conformity is supported by the completed file.
  • Batch records connect finished toys to their materials and evidence.
  • Changes to the product have been recorded and reviewed.
  • Affected tests have been repeated where necessary.
  • The file can be exported, retained and produced if requested.

Start building your Technical File

Bring your product definition, risk assessment, testing, material evidence, labelling and production records together in the CertHub app.

The free trial allows you to create one complete Technical File and see how the process works before choosing a paid plan.

Start your free Technical File

This information is intended to help 3D-printing businesses understand what a Technical File is and how it is assembled for ordinary toys in Great Britain. The exact content required depends on the product, its materials, construction and intended use. It does not replace the Toys (Safety) Regulations, the applicable standards or product-specific professional advice.

Official sources:
Toys (Safety) Regulations 2011: Great Britain
UK designated standards
Placing UKCA or CE-marked products on the market in Great Britain