Manufacturing & Engineering UK-wide

Place jewellery, toys, medical devices and other goods on the market

Each product in Division 32 carries its own conformity regime before it reaches the market. Most goods carry general product safety. Toys, personal protective equipment and medical devices have their own marking and registration rules. Articles of precious metal must be hallmarked. Work through the section that fits what you make.

Guide summary

Find the correct product safety rules for your goods before you place them on the market. Most consumer goods must meet the General Product Safety Regulations. Toys, medical devices and PPE have their own strict regimes, including marking and registration. The Office for Product Safety and Standards and local Trading Standards enforce these rules. You can face fines up to £20,000 and up to 12 months in prison for breaking the rules.

  • Find the correct safety rules for your product type
  • Meet the General Product Safety Regulations for most goods
  • Follow the Toys Regulations for products for children under 14
  • Apply UKCA or CE marking to your toys
  • Register medical devices with the MHRA before you sell them
  • Follow strict marking rules for personal protective equipment (PPE)
  • Hallmark goods made from precious metal at a UK assay office
  • Work with OPSS and local Trading Standards to comply
  • Know the penalties: fines up to £20,000 and 12 months in prison
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Related guides in General Compliance

Running a safe workshop is one half of the job. The other is meeting the rules that attach to the products themselves before they reach the market. Which apply depends on what you make — most goods carry the general product safety duty, while toys, personal protective equipment, medical devices and articles of precious metal have their own specific regimes that take precedence. Work through the sections that fit your products. Several bodies are involved: the Office for Product Safety and Standards (OPSS) and local Trading Standards for product safety, toys, PPE and hallmarking enforcement, the Medicines and Healthcare products Regulatory Agency (MHRA) for medical devices, and the UK assay offices for hallmarking.

A. Meet general product safety for consumer goods

Consumer products that fall outside a specific regime — jewellery, musical instruments, sports goods, brushes and miscellaneous goods — must be safe in normal and reasonably foreseeable use under the General Product Safety Regulations 2005, the residual catch-all enforced by OPSS and local Trading Standards. Where a specific regime applies (toys, medical devices, PPE) that regime takes precedence. In Northern Ireland the EU General Product Safety Regulation applies instead under the Windsor Framework.

B. Meet the Toys (Safety) Regulations for toys and games

If you make a product designed or intended for use in play by children under 14, it is a toy and must meet the essential safety requirements, undergo the relevant conformity-assessment procedure, carry conformity marking — UKCA, or CE which is still accepted on the GB market — and be supported by technical documentation and a declaration of conformity, with the required safety warnings. Enforced by OPSS and local Trading Standards. If you supply Northern Ireland, check that position separately, as it follows EU rules under the Windsor Framework.

C. Meet the PPE rules for safety equipment

If you make personal protective equipment — safety helmets, eye and hearing protection, hi-vis and protective clothing, gloves, respirators or fall-arrest harnesses — you must classify it by risk category, complete the relevant conformity assessment (with an approved body for Categories II and III), apply conformity marking (UKCA, or CE which is still accepted on the GB market), and draw up technical documentation and a declaration of conformity. Enforced by OPSS. If you supply Northern Ireland, check that position separately.

D. Meet the Medical Devices Regulations for medical and dental devices

If you make medical devices — surgical and dental instruments, dentures, crowns, orthopaedic and prosthetic appliances, or in-vitro diagnostic supplies — you must meet the essential requirements, classify the device by risk, complete the appropriate conformity assessment (with an approved-body certificate for the higher-risk classes), hold technical documentation, and operate post-market surveillance and vigilance reporting. UK-based manufacturers register with the Medicines and Healthcare products Regulatory Agency (MHRA). Overseas manufacturers must appoint a UK Responsible Person. Custom-made dental and orthopaedic appliances have a specific route. The regime is UK-wide, with separate Northern Ireland rules: the NI market requires CE marking, with the UKNI mark added alongside the CE mark where a UK Approved Body carries out the conformity assessment. The framework is being reformed, so check the current MHRA requirements and timelines for your device.

E. Hallmark articles of precious metal

If you make articles of gold, silver, platinum or palladium above the statutory exemption weights, the Hallmarking Act 1973 requires each article to be independently assayed and struck with a UK hallmark by one of the four UK assay offices (London, Birmingham, Sheffield and Edinburgh) before it is described or sold as precious metal. As the maker you send your articles to an assay office for hallmarking. It is an offence to describe or supply an unhallmarked article as being of precious metal in the course of trade. The British Hallmarking Council oversees the system and local Trading Standards enforce it. The regime applies across the United Kingdom.

  1. 1

    1. Check which product regime applies to what you make

    Most consumer goods carry general product safety. Toys, PPE, medical devices and precious-metal articles have their own specific regimes that take precedence.

  2. 2

    2. Complete conformity assessment and marking for regulated products

    For toys, PPE and medical devices, classify the product, complete the conformity assessment (with an approved body where required), apply the right marking (UKCA, or CE which is still accepted on the GB market; for medical devices in NI, CE marking, plus UKNI where a UK Approved Body is used), and hold your technical documentation and declaration.

  3. 3

    3. Register medical devices with the MHRA

    If you make medical devices, register with the MHRA (or appoint a UK Responsible Person if you are overseas), and operate post-market surveillance and vigilance.

  4. 4

    4. Hallmark precious-metal articles

    Send articles of gold, silver, platinum or palladium above the exemption weights to a UK assay office to be assayed and hallmarked before you describe or sell them as precious metal.

What to do next

With your safe-workshop spine and your product-market duties in place, confirm the whole picture with the other manufacturing compliance checklist. Start from the router if you are not sure which guides apply to you.

Official sources

Authoritative product-conformity, medical-device and hallmarking guidance.