UKCA marking: conformity assessment and documentation

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 showassessment to show the UKCAUK essential requirements have been met.

CE marked products

IfCurrently you’rethe continuinglaw toprovides placethat CEcertain marked products on the GB market until the 31 December 2024, you should note that where:

• UKmeet productEU regulationsrequirements, areincluding amended,CE youmarking, willcan havebe theplaced flexibilityon to choose between the UKCAGB andmarket CE markings until 31 December 2024
• EU2024. regulationsAs areset amended,out youabove, will need to follow the EUgovernment regulationis asintending itto appliedextend onthis 31recognition Decemberof 2020 to supply those goods tothat the GB market using the CE marking or meet theEU UKrequirements regulation and place a UKCA mark on the product

indefinitely.

If you’reyou are following European harmonised standards andto demonstrate that your product meets the EU essential requirements in the relevant DirectiveEU legislation, and you want to place CEthat markedproduct products on the GB market, you should also note the following:

1. ThisWhere willUK notlaw giveallows risefor toa ‘presumptionproduct ofto conformity’meet (whichthe canEU beessential counteredrequirements, bythere evidence)is withno thespecific essentialreference requirementsto inharmonised thestandards Directivegiving inrise relation to thosea goods‘presumption placedof onconformity’ with the GBessential market.requirements. However, manufacturerswhere mayboth continue the EU harmonised standards toand evidenceUK theydesignated havestandards metremain thealigned, essentialmanufacturers requirementsmay ofstill therely EUon Directivethe inharmonised casesstandard whereto itdemonstrate remainsthey alignedhave withmet the designatedrelevant standard.EU Toessential claimrequirements presumptionto ofplace conformitya forproduct goods placed on the GB market manufacturers must follow UK designated standards and use UKCA marking.market.
2. In a small number of cases where there is a difference between designated standards and European harmonised standards, the conformity assessment procedures that need to be complied with before the CE marked product can be placed on the GB market, may be affected.
3. If a designated standard has a restriction which the equivalent European harmonised standard used does not, you may need to take additional steps to bring that product into compliance with the safety requirements before placing the product on the GB market.

You should consult the sector-specific guidance for your product. You can speak to your solicitor or trade association if you’re unsure which regulations apply to your products.

Self-declaration for the UKCA marking

If you self-declare for the CE marking,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	ProductsAll products except where alldesignated standards covering the essential requirements areeither covereddo not exist or have not been applied (either in full or in part) by designatedthe standardsmanufacturer. andOr where one or more of the manufacturerdesignated standards has appliedbeen thesepublished standardswith a restriction.
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 forcovering regulationthe 6essential (2)requirements either do not exist or have not been applied (either in full or in part) by the manufacturermanufacturer.
The Pressure Equipment (Safety) Regulations 2016	Category I pressure equipment
Construction Products Regulations (Regulation (EU)(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 machinemachinery which is not in Schedule 2, Part 4 of the Regulations. Any machinemachinery 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 all 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)(EU) 2016/425 as brought into UKinto UK law and amended)	Category I personal protective equipment
	Ecodesign for Energy-Related Products Regulations 2010	All products listed in Schedule 1 with the exception of boilers as specified in retained Commission Regulation (EU)(EU) 813/2013

Mandatory third-party conformity assessment for the UKCA markingthe UKCA marking

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

TheWhilst governmentthe willcurrent bringposition forwardis legislation that will require conformity assessment for new product types after 11pm on 31 December 2024 toall beproducts carriedmust outbe byUKCA amarked, UKwhich Approvedrequires Body. The conformity assessment proceduresby anda modulesUK applicableApproved arebody, the samegovernment asintends thoseto thatbring wereforward requiredlegislation forbefore the CEthis marking.

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

The government will be introducing legislation to allowextend conformityrecognition assessmentof activitiesgoods undertakenthat bymeet EU-recognisedEU Conformityrequirements Assessment(including Bodies (CABs), for CE certificationmarking), beforeindefinitely 11pmfor onmany 31products.

This Decembermeans 2024,that togoods bethat usedmeet byEU manufacturersrequirements, toincluding declarethe existingapplicable productconformity typesassessment asprocedures compliant(which within UKCAsome requirements.cases Products must stillbe bearundertaken theby UKCAEU markingrecognised andbodies) willcan needcontinue to undergobe conformityplaced assessmenton with a UK Approved Body at the expiryGB ofmarket.

Reducing there-certification certificateand orre-testing aftercosts 31for DecemberUKCA 2027, whichever is sooner.

marking

BeforeThe 11pmcurrent onposition 31is Decemberthat 2024,where ifa anmanufacturer EU-recognisedhas CABtaken hassteps completedunder thean relevantEU conformity assessment activitiesprocedure applyingprior to a31 product,December this2024 wouldbut allowthe manufacturersproduct tohas applynot thebeen UKCAplaced markon without the needGB formarket anyby UKthat Approveddate, Bodythose involvement.steps Theywill couldbe continuerecognised toand placewill theircount goodstowards on the marketequivalent onconformity theassessment basisprocedure ofrequired theirunder existing CE certification following the endUKCA ofregime this(until year,any for the lifetime of the certificate issued,expires or until 31 December 20272027, (whicheverwhichever is the sooner).

WhereThis manufacturersprovision arewas usingaimed conformityat assessmentensuring underthat existingmanufacturers CEdo certificationnot beforehave 11pmto onundertake 31expensive Decemberre-testing, 2024once asgoods thethat basismeet toEU ensurerequirements compliancewere withno UKCAlonger requirementsrecognised foron theirthe products,GB wemarket. recommendHowever, thatas theypart includeof in the UKprocess Declarationfor ofextending Conformity the listrecognition of relevantgoods UKthat designatedmeet standards and equivalent EU harmonisedrequirements standardsbeyond that31 applyDecember to2024, their product, as well as details of the EU-recognisedgovernment CABwill (oralso CABbe recognisedconsidering underthis anprovision, EUsince Mutualit Recognitionmay Agreementno withlonger ahave thirdany country)value whichin carriedits outcurrent the conformity assessment procedures.form.

This measure applies across all module types for the following regulations:regulations as they apply in GB:

• 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 (with respect to boilers in accordance with Article 4 of Commission Regulation (EU)(EU) No 813/2013)
• 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. The relevant period is specified in the applicable legislation.

This information can be requested at any time (within the time period set out by legislation) by market surveillance or enforcement authorities to check that your product conforms with the regulatory requirements.

The information manufacturersyou must keep will vary depending on the specific legislation relevant to your product.product, but if requested you must provide enforcement authorities with all information and documentation necessary to demonstrate that a product is in conformity. This information must be provided in English.

YouThis mustcould keepinclude, generalbut recordsis of:not necessarily limited to, the following:

• how the product is designed and manufactured
• how the product has been shown to conform to the relevant requirements
• the addressaddresses 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 markinga UKCA marking before they are placed on the market. We recommend that manufacturers have their UK Declaration of Conformity and their EU Declarationtheir 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 or enforcement authorities on request.

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

• yourthe (the manufacturer’s) name and full business address of the manufacturer and that of your authorised representative (if applicable)
• the product’s serial number, model or type identification
• a statement, stating you (the manufacturer) 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
• references to the relevant designated standards, including the date of the standard or references to other technical specifications
• 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)than EU legislation) (ODS, 5.29 KB). This can be listed as a reference to the base statutory instrument number (where applicable) or the full title.title
• UK designated standards rather than standards cited in the Official Journal of the European Union

Relevant UK and EU legislation

In many areas the current EU legislationcurrent EU legislation for specific products has corresponding UK legislation:

EU Legislation	UK Legislation
Toy Safety - Directive 2009/48/EC	Toys (Safety) Regulations 2011
Recreational craft and personal watercraft - Directive 2013/53/EU2013/53/EU	Recreational Craft Regulations 2017
Simple Pressure Vessels - Directive 2014/29/EU2014/29/EU	Simple Pressure Vessels (Safety) Regulations 2016
Electromagnetic Compatibility - Directive 2014/30/EU2014/30/EU	Electromagnetic Compatibility Regulations 2016
Low Voltage Directive 2014/35/EU2014/35/EU	Electrical Equipment (Safety) Regulations 2016
Non-automatic Weighing Instruments - Directive 2014/31/EU2014/31/EU	Non-automatic Weighing Instruments Regulations 2016
Measuring Instruments - Directive 2014/32/EU2014/32/EU	Measuring Instruments Regulations 2016
Lifts - Directive 2014/33/EU2014/33/EU	Lifts Regulations 2016
ATEX - Directive 2014/34/EU2014/34/EU	Equipment and Protective Systems Intended for use in Potentially Explosive Atmospheres Regulations 2016
Radio equipment - Directive 2014/53/EU2014/53/EU	Radio Equipment Regulations 2017
Pressure equipment - Directive 2014/68/EU2014/68/EU	Pressure Equipment (Safety) Regulations 2016
Personal protective equipment - Regulation (EU)(EU) 2016/425	Regulation 2016/425 on personal protective equipment as it applies in GB
Gas appliances - Regulation (EU)(EU) 2016/426	Regulation 2016/426 on gas appliances as it applies in GB
Machinery Directive 2006/42/EC	Supply of Machinery (Safety) Regulations 2008
Outdoor Noise Directive 2000/14/EC	Noise Emission in the Environment by Equipment for use Outdoors Regulations 2001
Ecodesign of energy-related products - Directive 2009/125/EC	Ecodesign for Energy-Related Products Regulations 2010