Technical Documentation Requirements in the UK: A Complete Guide

Technical documentation is mandatory for various products sold in the United Kingdom, including toys, electronics, machinery, PPE and medical devices. In this guide, we explain how you can find technical documentation requirements for your products and when you may need to submit it to a third party for review.

What is technical documentation?

Technical documentation, in this context, is a set of documents mandated by UK product regulations. Products that require UKCA marking must generally be supported by technical documentation.

Is technical documentation mandatory in the UK?

Technical documentation is mandatory for products covered by one or more UK regulations which require UKCA marking. That said, many companies create technical documentation even if this is not mandatory for their products.

For which products is technical documentation required in the UK?

Here are some examples of products which are subject to technical documentation requirements in the United Kingdom:

• Consumer electronics
• Electrical appliances
• Machinery
• Toys
• Personal Protective Equipment (PPE)
• Medical devices

Which UK regulations mandate technical documentation?

Below is a list of regulations in the United Kingdom that set technical documentation requirements:

UK Regulation	Elements / Information
The Toys (Safety) Regulations 2011	Schedule 4
The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012	Schedule 1, Part 4
The Electromagnetic Compatibility Regulations 2016	Schedule 2 (Module A), or Schedule 3 (Module B)
The Electrical Equipment (Safety) Regulations 2016	Schedule 2
The Radio Equipment Regulations 2017	Schedule 5
The Ecodesign for Energy-Related Products Regulations 2010	Schedule 1A, Part 1
The Supply of Machinery (Safety) Regulations 2008	Schedule 2, Part 7, Annex VII
Personal Protective Equipment Regulation (EU) 2016/425	Annex III
The Medical Devices Regulations 2002	Annexes II and III of the Medical Devices Regulation (EU) 2017/745
Gas Appliances Regulation (EU) 2016/426	Annex III
The Measuring Instruments Regulations 2016	Part 4, Chapter 2

Note that these are just examples of such regulations. There are other UK regulations which also set technical documentation requirements.

What should be included in the technical documentation?

The exact list of information and files which must be included in the technical documentation depends on the applicable UK regulations. This, in turn, depends on the product and its parameters.

That said, the following must often be included in the technical documentation:

1. Product descriptions

2. Technical drawings

3. Bill of materials

4. Packaging artwork

5. List of applied designated standards

6. List of UK regulations applicable to the product

7. User instruction files

8. Product label files

9. Test reports

10. UK Declaration of Conformity copy

There is no exact format or template. The technical documentation for a toy looks very different from the technical documentation for an electronic appliance.

Example – The Electrical Equipment (Safety) Regulations 2016

Source: GOV.UK

How do I know what to include in the technical documentation?

You must first identify all applicable UK regulations for your product. For example, an electronic toy may be subject to the following regulations:

• The Toys (Safety) Regulations 2011
• The Electromagnetic Compatibility Regulations 2016
• The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012
• The Radio Equipment Regulations 2017

Each of these UK regulations has its own list of technical documentation requirements. These overlap, meaning that the same items are often listed in each of these regulations.

That being said, you will still need to make sure that your unified technical documentation contains all files and information required by all applicable UK regulations.

Who can create the technical documentation?

The technical documentation is normally created by the manufacturer. Note that manufacturers also include companies that contract production of their own designed and branded items to external factors.

Are UK importers required to create technical documentation?

No, UK importers are not responsible for creating the technical documentation. That said, UK importers are responsible for requesting technical documentation and ensuring that it contains the files and information mandated by all applicable UK regulations.

That is often easier said than done when dealing with overseas manufacturers that may not have a clue about UK product regulations and technical documentation requirements.

Do we need to submit the technical documentation for approval?

This is only necessary in case your product must be certified by a UK Approval Body, or if requested by a UK government department. In most other cases, there is no such approval involved.

When are UK companies required to share the technical documentation?

Yes, UK companies must provide technical documentation if requested by the Office for Product Safety and Standards (OPSS) or other government departments in the United Kingdom. This can occur in the case of random product safety checks or if your product is subject to investigation for other reasons.

That being said, they are more likely to request the UK Declaration of Conformity, test reports, and label copies to determine if your product meets applicable requirements.

The technical documentation is usually only relevant if a more throughout assessment is required.

Do we need to submit technical documentation to Amazon UK?

I am not aware of any instance in which Amazon UK has required a seller to submit technical documentation. This could happen, but they normally look at the UK DoC, test reports, and label files.

For how long should the technical documentation be stored?

UK manufacturers and importers must maintain a copy of the technical documentation for 10 years. This counts from the last batch sold of a particular product, not the initial date of introduction.

Are EU and UK technical documentation requirements differ?

The concept of technical documentation originates in EU regulations and directives, which are also part of UK regulations after Brexit. However, the UK is not moving in lockstep with the EU. As such, EU and UK regulations diverge, which also means that the technical documentation requirements can differ.

Is UK technical documentation accepted in the EU?

Only to the extent that these overlap with EU technical documentation requirements. Luckily, that is often the case.

For example, a PCB schematic or Bill of Materials would likely be equally valid for both the EU and UK.

There are some instances where there are differences, though. For example, UK technical documentation includes a UK declaration of Conformity and label files, which are not accepted in the EU.

Note: Contains public sector information licensed under the Open Government Licence v3.0.