Choose the right conformity assessment route

Before you can apply UKCA or CE marking to your product, you must complete the correct conformity assessment procedure. The route you follow depends on your product's risk level and the specific legislation that applies to it. Getting this wrong can invalidate your marking and expose you to enforcement action by the Office for Product Safety and Standards (OPSS).

This guide explains how to determine which conformity assessment route applies to your product, what each route involves, and when you need to involve a UK Approved Body.

Understanding conformity assessment modules

UK product legislation uses a modular system derived from retained EU law. Each product regulation specifies which conformity assessment modules are available. The modules range from manufacturer self-declaration to full quality assurance audited by an independent body.

The most common modules are:

• Module A (Internal production control): The manufacturer carries out all assessment internally. No third-party body is involved. You conduct your own testing, compile technical documentation, and issue a UK Declaration of Conformity. This is available for most lower-risk products.
• Module B (EU/UK-type examination): A UK Approved Body examines a representative sample or technical design of your product and certifies that it meets the essential requirements. Module B is always followed by a production-phase module (C, D, E, or F).
• Module C (Conformity to type): Following a Module B certificate, the manufacturer ensures production matches the approved type. A UK Approved Body may carry out product checks at random intervals.
• Module D (Quality assurance of production): The manufacturer operates an approved quality management system for production, final inspection, and testing. A UK Approved Body audits the system.
• Module E (Quality assurance of product): Similar to Module D but focused on final product inspection and testing under an approved quality system.

Determining your assessment route

Follow these steps to identify which conformity assessment procedure applies to your product:

1. Identify the applicable product regulation. Check which of the 21 product regulations (or sector-specific regulations) covers your product. Each regulation lists the conformity assessment procedures available for different product categories within its scope.
2. Check the risk classification. Many regulations divide products into risk categories. For example, the Personal Protective Equipment Regulations classify PPE into Category I (simple design, minimal risks), Category II (intermediate risks), and Category III (complex design, serious risks). Higher categories require third-party assessment.
3. Look for Annex listings. Some regulations (such as the Machinery Regulations) list specific product types in annexes that require mandatory third-party conformity assessment. If your product appears on such a list, self-declaration is not available.
4. Check for UK designated standards. If a designated standard exists for your product and you follow it in full, you benefit from a presumption of conformity with the essential requirements. This does not change which module you must follow, but it simplifies demonstrating compliance.

Self-declaration (Module A): when you can assess your own product

Self-declaration is the most common route. For the majority of products covered by the 21 UKCA/CE product regulations, the manufacturer can declare conformity without involving a third party. This route is appropriate when:

• The relevant regulation permits Module A for your product type
• Your product does not fall into a higher risk category requiring third-party assessment
• You have the technical capability to test and verify your product against the essential requirements

Self-declaration does not mean no testing. You must still carry out rigorous internal testing, compile a complete technical file, and issue a UK Declaration of Conformity. If OPSS investigates your product and finds your self-assessment was inadequate, you face enforcement action including potential criminal prosecution.

Third-party assessment: when you need a UK Approved Body

You must use a UK Approved Body when the applicable product regulation requires it for your product type. Common examples include:

• Category III PPE (respiratory protection, fall protection, chemical protection) - requires Module B type examination plus Module C or D
• Pressure equipment above certain pressure/volume thresholds - requires Module B plus production-phase module
• Gas appliances - all require UK-type examination (Module B)
• Lifts - safety components require third-party assessment
• ATEX equipment for explosive atmospheres - Category M1 and Category 1 equipment require third-party assessment
• Machinery listed in Annex IV of the Machinery Regulations (e.g. certain woodworking machines, presses, injection moulding machines) - where no designated standard has been applied

Find an Approved Body using the UKMCAB (UK Market Conformity Assessment Bodies) database. Search by product type, regulation, and conformity assessment module to identify bodies designated for your specific needs.

Converting from CE to UKCA marking

If your product already holds valid CE marking based on EU conformity assessment, you can use the fast-track route to add UKCA marking without repeating the full assessment. This works because UK and EU product requirements remain largely aligned for the 21 covered regulations.

To use the fast-track route:

1. Confirm your product has valid CE marking with a current EU Declaration of Conformity
2. Draw up a UK Declaration of Conformity, referencing the EU legislation your product meets
3. Affix the UKCA marking to your product alongside or instead of the CE marking
4. Retain the UK Declaration and supporting documentation for 10 years

Note: Under the October 2024 policy change, CE marking is now recognised indefinitely on the GB market for the 21 covered product regulations. You are not required to convert to UKCA if you already have valid CE marking. However, holding both markings provides maximum flexibility if rules change in future.