Manufacturers - Frequently asked questions

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Manufacturers

What safety requirements must my products meet?

Product supply legislation covers products such as:

  • machinery, safety components, interchangeable equipment, lifting accessories
  • goods and passenger lifts, cableways, pressure systems, gas appliances
  • electrical, radio and personal protective equipment
  • equipment for use in potentially explosive atmospheres

If any legislation is relevant to your product, then you (or, in some cases, your authorised representative ) must meet all of the essential requirements of that legislation.

This must be done before you can place the product on the market, or before you bring it into use for the first time. The essential requirements are laid out in each regulation. Failure to adequately meet these legal requirements may be a criminal offence, for which (in many cases) the courts can impose unlimited fines.

What do manufacturers have to do?

Before placing products on the market, manufacturers (or their authorised representative) must:

  • design and construct a safe and compliant product
  • undertake the relevant conformity assessment procedure for that product (which, in some cases, requires the involvement of a third party to verify compliance )
  • draw up a technical file demonstrating how the essential requirements have been met, keep it for at least 10 years and make it available to the authorities on request
  • affix appropriate conformity marking and labelling
  • produce a Declaration of Conformity (or a Declaration of Incorporation for partly completed machinery), and for some construction products, a Declaration of Performance
  • provide user instructions, in the language of the end user

Manufacturers, and those who take on the manufacturer's role (this may include importers who place goods on the market for the first time), also have other responsibilities for product traceability, undertaking testing/examination, and managing risk and non-compliance for products already placed on the market, by taking action for compliance, withdrawal and recall from the market in appropriate cases, and to notify and cooperate with the authorities when required.

What does the UKCA mark mean?

By affixing the UKCA  marking, the manufacturer is claiming that the product complies with all product safety legislation applicable to that product. However, UKCA marking in itself does not guarantee safety, nor is it a quality mark. CE marked products will continue to be recognised on the UK market up to the 31st December 2021, however businesses are encouraged to move to the UKCA marking as soon as possible.

Intermediate suppliers (distributors) and users of work equipment can rely on the UKCA mark giving a presumption of conformity with the relevant product supply legislation (and compliance with regulation 10 of PUWER), provided that the product:

  • is free from clear and obvious defects (ie the ones users are / should be aware of, such as damaged or missing guarding, exposed electrical conductors, etc)
  • comes with suitable instructions in English
  • comes with (in most cases) a Declaration of Conformity in English

How should user instructions be provided?

In all cases they must be in the language of the end user (English for the UK market) and meet the minimum requirements as specified in the relevant product legislation.

Those parts essential for health and safety should normally be provided with the product in a printed form.

Where can I find standards that relate to my product?

British, European and International standards concerning a wide range of products and their characteristics are published by the British Standards Institution and copies can be purchased through the BSI website. Other European language versions may be available through the national standards bodies of other member states.

The titles of UK designated standards that support one or more UK product supply legislation are definitively published by the Secretary of State. A list with this legislation and the supporting standards is available on GOV.UK.

What legal status do standards have?

In themselves, most standards only provide guidance. It is the essential requirements of the relevant product supply legislation which must be met in law. However, where a manufacturer declares on the Declaration of Conformity compliance with a standard, the manufacturer must meet its requirements in full. Full compliance with a designated or harmonised standard gives presumption of conformity with one or more essential requirements of the relevant product legislation.

What is 'presumption of conformity'?

Manufacturers normally have to show how their particular product complies with all relevant essential requirements of the product legislation relating to it. This is done through conformity assessment - which can involve a detailed and complex assessment and the collection of significant evidence in a technical file.

However, where a product fully meets the requirements of a written standard for that product, or an aspect of safety relevant to that product (eg the safety distances to dangerous parts as given in the relevant standard), the standard may give the manufacturer a 'presumption of conformity' with one or more essential requirements. In other words, the manufacturer then may not need to show in as much detail how the product complies with the relevant legislation for the characteristics of the standard which the manufacturer has met . This often shortens and simplifies the conformity assessment process and requires less evidence to be produced for the technical file.

To do this, manufacturers must check that a standard can give a presumption of conformity and their product must be within scope of that standard. The basis on which a standard may give presumption of conformity must be verified.

What is covered by the Supply of Machinery (Safety) Regulations 2008?

The Supply of Machinery (Safety) Regulations 2008 apply to almost all machinery and partly completed machinery. Certain other products (listed in Regulation 4) also come within scope of the regulations in the same way as machinery:

  • interchangeable equipment
  • safety components
  • lifting accessories
  • chains, ropes and webbing
  • removable mechanical transmission devices

However, some machinery-related products are excluded, see Schedule 3 (eg fairground equipment, certain means of transport, certain electrical and electronic products). Other products may be excluded, where covered by other more specific product legislation (such as medical devices which are also machines, traditional passenger and goods lifts, but not construction or slow moving lifts).

Another key exclusion is machinery powered by human or animal effort. However, lifting machines operated by directly applied human effort remain in scope.

When do I have to use a Conformity Assessment body?

Many products and most machinery do not have to undergo third-party assessment, completed by a conformity assessment body. However, the conformity assessment of certain products requires independent assessment by a conformity assessment body, prior to the product being conformity marked and placed on the market. This includes certain types of higher risk machinery, equipment and safety components, such as:

  • cableways and their components
  • pressure plant
  • gas appliances
  • lifts
  • equipment for use in potentially explosive atmospheres
  • logic units delivering a safety function
  • protective devices designed to detect the presence of persons

The conformity assessment body's assessment may take the form of type examination, quality assurance or other means - as specified for that product by the relevant  product safety supply legislation. If satisfied the Conformity Assessment Body will issue an EC Type-examination certificate to the manufacturer (these are normally of limited validity 5 years from date of issue provided products made in series do not change).

When do I have to use an approved body?

Many products and most machinery do not have to undergo third-party assessment, completed by a conformity assessment or approved body. However, the conformity assessment of certain products requires independent assessment by an approved body, prior to the product being UK marked and placed on the UK market. This includes certain types of higher risk machinery, equipment and safety components, such as:

  • cableways and their components
  • pressure plant
  • gas appliances
  • lifts
  • equipment for use in potentially explosive atmospheres
  • logic units delivering a safety function
  • protective devices designed to detect the presence of persons

The approved body's assessment may take the form of type examination, quality assurance or other means - as specified for that product by the relevant product legislation. If satisfied the Approved Body will issue a Type-examination certificate to the manufacturer (these are normally of limited validity 5 years from date of issue provided products made in series do not change).

When is an installer a manufacturer?

Installers constructing machinery in situ from parts not supplied and intended as a complete product(s) or users making and installing a machine for their own use become the manufacturer for the purposes of the Supply of Machinery (Safety) Regulations, and have all the duties for compliance to fulfil as the Responsible Person. This is the case for many powered gates, large complex machinery and also for goods/passenger lifts which only exist as a complete product once installed in the environment of use.

Updated: 2021-01-15