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Guidance UKCA marking: conformity assessment and documentation

ID 17397 | | Visite: 559 | Documenti Riservati Marcatura CEPermalink: https://www.certifico.com/id/17397

Guidance UKCA marking

Guidance UKCA marking: conformity assessment and documentation / Gov.uk August 2022

ID 17397 | 19.08.2022 / Documento in allegato (Gov.uk Published 10 August 2022)

How to make sure that your products are properly checked for conformity and your technical documents are managed correctly.

Conformity assessment routes

Certain conformity assessment procedures allow for self-declaration of conformity by the manufacturer.

Other regulations, for those typically more ‘high-risk’ products, may require third-party conformity assessment.

You should check the sector specific guidance which applies to your product to find out whether you can self-declare or need to use a third-party conformity assessment to show the UKCA requirements have been met.

Self-declaration for the UKCA marking

If you self-declare for the CE marking, you can still self-declare for the UKCA marking.

Legislative areas where self-declaration of conformity for UKCA marking is permitted, and in some, instances may be required:

Legislation

Scope of products which can be self-declared

Electromagnetic Compatibility Regulations 2016

All products

Toy (Safety) Regulations 2011

Products where all essential requirements are covered by designated standards and the manufacturer has applied these standards

The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012

All products

Medical Devices Regulations 2002

Some Class 1 devices

Radio Equipment Regulations 2017

All products except where designated standards for regulation 6 (2) either do not exist or have not been applied (either in full or in part) by the manufacturer

The Pressure Equipment (Safety) Regulations 2016

Category I pressure equipment

Construction Products Regulations (Regulation (EU) 305/2011 as brought into UK law and amended)

Products within scope of System 4

Recreational Craft Regulations 2017

Certain categories of recreational craft as specified in the legislation

The Electrical Equipment (Safety) Regulations 2016

All products

The Supply of Machinery (Safety) Regulations 2008

Any machine which is not in Schedule 2, Part 4 of the Regulations.

Any machine that is in Schedule 2, Part 4 where the requirements of all relevant designated standards have been applied in full and where those standards cover the applicable essential requirements.

The Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 2016

Equipment-group II, equipment category 3

Personal Protective Equipment Regulations (Regulation (EU) 2016/425 as brought into UK law and amended)

Category I personal protective equipment

Mandatory third-party conformity assessment for the UKCA marking

Where mandatory third-party conformity assessment was required for CE marked products, it’s also required for UKCA marked products.

Conformity assessment for new product types after 31 December 2022 needs to be carried out by a UK-Approved Body. The conformity assessment procedures and modules applicable are the same as those that were required for the CE marking.

Reducing re-certification/re-testing costs for UKCA marking

The government will be introducing legislation to allow conformity assessment activities undertaken by EU-recognised Conformity Assessment Bodies (CABs), for CE certification before 31 December 2022, to be used by manufacturers to declare existing product types as compliant with UKCA requirements. Products must still bear the UKCA marking and will need to undergo conformity assessment with a UK Approved Body at the expiry of the certificate or after 5 years (31 December 2027), whichever is sooner.

Before 31 December 2022, if an EU-recognised CAB has completed the relevant conformity assessment activities applying to a product, this would allow manufacturers to apply the UKCA mark without the need for any UK Approved Body involvement. They could continue to place their goods on the market on the basis of their existing CE certification following the end of this year, for the lifetime of the certificate issued, or until 31 December 2027 (whichever is sooner).

Where manufacturers are using conformity assessment under existing CE certification before 31 December 2022 as the basis to ensure compliance with UKCA requirements for their products, we recommend that they include in the UK Declaration of Conformity the list of relevant UK designated standards and equivalent EU harmonised standards that apply to their product, as well as details of the EU-recognised CAB (or CAB recognised under an EU Mutual Recognition Agreement with a third country) which carried out the conformity assessment procedures.

This measure applies across all module types for the following regulations:

- Noise Emission in the Environment by Equipment for Outdoor Use Regulations 2001
- Supply of Machinery (Safety) Regulations 2008
- Ecodesign for Energy-Related Products Regulations 2010
- Toys (Safety) Regulations 2011
- Explosives Regulations 2014
- Pyrotechnic Articles (Safety) Regulations 2015
- Electromagnetic Compatibility Regulations 2016
- Simple Pressure Vessels (Safety) Regulations 2016
- Lifts Regulations 2016
- Pressure Equipment (Safety) Regulations 2016
- Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 2016
- Non-automatic Weighing Instruments Regulations 2016
- Measuring Instruments Regulations 2016
- Recreational Craft Regulations 2017
- Radio Equipment Regulations 2017
- Regulation 2016/425 on personal protective equipment as it applies in GB
- Regulation 2016/426 on gas appliances as it applies in GB

The UK Market Conformity Assessment Bodies (UKMCAB) database lists all bodies which can provide conformity assessment for the UK market.

Technical documentation

Record keeping

You, or your authorised representative (where allowed for in the relevant legislation), must keep documentation to demonstrate that your product conforms with the regulatory requirements.

This must generally be kept for 10 years after the product is placed on the market.

This information can be requested at any time by market surveillance or enforcement authorities to check that your product conforms with the regulatory requirements.

The information manufacturers must keep will vary depending on the specific legislation relevant to your product.

You must keep general records of:

- how the product is designed and manufactured
- how the product has been shown to conform to the relevant requirements
- the address of the manufacturer and any storage facilities

You should keep the information in the form of a technical file which can be supplied if requested by a market surveillance authority.

UK Declaration of Conformity

The UK Declaration of Conformity is a document which must be drawn up for most products lawfully bearing a UKCA marking before they are placed on the market. We recommend that manufacturers have their UK Declaration of Conformity and their EU Declaration of Conformity in separate documents.

In the document you as the manufacturer, or your authorised representative (where allowed for in the relevant legislation), should (among other things):

- declare that the product is in conformity with the relevant regulatory requirements
- make sure the document has the name and address of the manufacturer (or your authorised representative) together with information about the product and the conformity assessment body (where relevant)

The UK Declaration of Conformity should be available to market surveillance authorities on request.

The information required on the UK Declaration of Conformity is largely the same as what was required on an EU Declaration of Conformity. This can vary depending on the applicable legislation but generally should include:

- your (the manufacturer’s) name and full business address and that of your authorised representative (if applicable)
- the product’s serial number, model or type identification
- a statement, stating you take full responsibility for the product’s compliance
- the details of the approved body which carried out the conformity assessment procedure (if applicable)
- the relevant legislation with which the product complies
- the name and signature of the person authorised to sign on behalf of the manufacturer or their authorised representative
- the date the declaration was issued
- supplementary information (if applicable)

You will need to list:

- relevant UK legislation (rather than EU legislation) (in attachment). This can be listed as a reference to the base statutory instrument or the full title.
- UK designated standards rather than standards cited in the Official Journal of the European Union (Gov.uk)
...

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Gov.uk
Published 10 August 2022

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Allegato riservato Guidance UKCA marking - conformity assessment and documentation Rev. 00 2022.pdf
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Allegato riservato uk-eu legislation list.xlsx
Gov.uk - 10 August 2022
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