Sector-Specific

Choose the right conformity assessment route

Find the product regulations that cover your product, check which assessment modules each allows for your product's risk level, then either self-declare or use an Approved Body. Once you have followed the route, build the technical file and draw up the declaration of conformity.

Product compliance and marking EnglandScotlandWales

Before you can apply UKCA or CE marking, you must assess whether your product meets the essential requirements in the regulations that cover it. The route depends on those regulations and on your product's risk level. Some products you can assess yourself. Others need a third-party conformity assessment body.

Find the regulations that cover your product

A product often falls under more than one regulation, and each one sets its own routes. A product marked with UKCA or CE has to comply with all of them. Look up your product in the government's table of product regulations by sector, which also lists the sectors, such as medical devices and construction products, that have rules outside the UKCA and CE regimes.

See which modules the regulation allows

A regulation names the modules you may follow for each category of product. The modules run from your own checks to a full quality system audited by a third party.

Module A
Internal production control
Module B
Type examination by a third party
Module C
Conformity to type
Module D
Quality assurance of production
Module E
Product quality assurance
Module F
Product verification
Module G
Unit verification
Module H
Full quality assurance

The Pressure Equipment (Safety) Regulations 2016 show how this works. Category I equipment follows Module A, which you can do yourself. Category III needs a type examination (Module B) paired with a production module, such as D or F, or Module H, and each of these involves an Approved Body. You may always choose a procedure for a higher category if it is available.

Decide whether you can self-declare

For these regulations, the manufacturer can self-declare conformity under the UKCA regime.

Products you can self-declare

Regulation Products you can self-declare
Aerosol Dispensers Regulations 2009 All products
Electrical Equipment (Safety) Regulations 2016 All products
Electromagnetic Compatibility Regulations 2016 All products
Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012 All products
Measuring Container Bottles (EEC Requirements) Regulations 1977 All products
Personal Protective Equipment Regulations (Regulation (EU) 2016/425 as brought into UK law and amended) Category I
Pressure Equipment (Safety) Regulations 2016 Category I
Radio Equipment Regulations 2017 All products, unless designated standards covering the essential requirements do not exist or you have not applied them
Toy (Safety) Regulations 2011 All products, unless designated standards covering the essential requirements do not exist, you have not applied them, or one was published with a restriction
Supply of Machinery (Safety) Regulations 2008 Machinery not listed in Schedule 2, Part 4, and Part 4 machinery where you have applied all relevant designated standards in full and they cover every essential requirement
Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 2016 Equipment group II, category 3
Ecodesign for Energy-Related Products Regulations 2010 Products in Schedule 1 except the boilers covered by retained Commission Regulation (EU) 813/2013
Noise Emission in the Environment by Equipment for use Outdoors Regulations 2001 Products subject to noise marking only, as listed in Schedule 2
Recreational Craft Regulations 2017 Certain categories of craft, as the regulations specify
Medical Devices Regulations 2002 Some Class I devices
Construction Products Regulation (retained) Products under assessment and verification of constancy of performance System 4

If your regulation is not in the table, read its conformity assessment provisions to confirm whether a third party is needed. Self-declaring does not reduce your responsibility. You remain responsible for assessing every risk, identifying the requirements and documenting how you meet them. Following a UK designated standard gives you a presumption of conformity, but the presumption can be challenged and does not replace the legal requirements. For toys and radio equipment, it also decides whether you can self-declare at all.

Use an Approved Body when the regulation requires it

Where a regulation requires a third-party assessment, use an Approved Body.

Consider the EU route

You may follow recognised EU requirements instead. A CE-marked product can be placed on the Great Britain market where the UK recognises the EU requirements for that regulation, but third-party assessment under the CE regime must come from an EU Notified Body. Fast-Track UKCA lets you apply the UKCA marking using either UK or recognised EU conformity assessment procedures for each regulation. Where several regulations apply, you can mix UK and EU procedures.

Build the technical file

Once you have followed your route, you must prepare a technical file.

Draw up the declaration of conformity

When you are satisfied the product complies, you draw up the declaration of conformity.

Official guidance