UKCA

UKCA Marking

The approval for Great Britain after the Brexit

New requirements for product approvals in the UK

In February 2020, the decision was made that the United Kingdom will leave the EU. This step was completed on January 1, 2021, with the consequence that England, Scotland, Wales and Northern Ireland are no longer part of the European Union with its now remaining 27 member states.
This also has an impact on the approval of products (with radio technologies).

Within the scope of the approval or the product launch, you as the manufacturer are responsible,

  • that your product complies with the relevant GB (England, Scotland and Wales only) or UK regulations
  • as well as for the preparation of the documentation, e.g. the declaration of conformity

What do manufacturers need to be aware of?

For manufacturers who already have products approved and in circulation in the UK, there is first of all good news:

The product approval (CE marking) for products that were already in circulation in the UK before 01.01.2021 and were thus imported, remain valid and the products can continue to be sold in the UK.

Manufacturers can usually provide evidence of placing on the market using any relevant document commonly used in business transactions, including

  • Sales contracts for goods that have already been manufactured and meet the legal requirements
  • Invoices
  • Documents relating to the shipment of goods for distribution.

For manufacturers wishing to authorize products for the UK after January 1, 2021, there are two options for market approval:

  • the CE marking, which will continue to be valid in a transitional phase until 12/31/2021
  • the UKCA certification (UKCA = UK Conformity Assessed)

Important: The relevant economic operator (whether manufacturer, importer or dealer/distributor) bears the burden of proof to demonstrate that the goods were placed on the market before January 1, 2021. This also includes the consideration of changed safety and import regulations, which can vary from industry to industry (e.g. medical devices).

The UKCA certification for the United Kingdom

Effective date and transition period

The UKCA approval is already valid from January 1, 2021 and can be used for market approval for the United Kingdom.

Within the framework of a transition phase, which is valid until December 31, 2021, manufacturers can continue to approve products in accordance with the previously valid specifications for a CE marking, provided that the EU specifications also correspond to the specifications of the United Kingdom.

Despite the transition period granted by the UK authorities until December 31, 2021, the UK authorities make it clear that manufacturers should address and implement the new UKCA approval process for the UK as soon as possible.

It is important to note here that CE marking of medical devices will continue to be recognized in the UK until June 30, 2023. This also includes medical devices with radio functions.

The approval process for a UKCA certification

If you are already seeking UKCA certification now – despite the transition period – the approval process for your product will change. UKCA stands for UK Conformity Assessed and in order to achieve this status, the previously valid directives must be replaced by the comparable UK directives and the tests must also be adapted accordingly. According to the current status, this concerns the following directives and guidelines, among others:

EU legislation UK legislation
Electromagnetic Compatibility Directive (EMCD) 2014/30/EU Electromagnetic Compatibility Regulations 2016
Low Voltage Directive (LVD) 2014/35 Electrical Equipment (Safety) Regulations 2016
Radio Equipment Directive (RED) 2014/53/EU Radio Equipment Regulations 2017

It is important to note that the directives mentioned are largely identical to the comparable EU directives.

This means that the process of a self-declaration (in this case UK self-declaration) is still possible for standardized standards. However, care must be taken to ensure that the terminologies for the UK variant are correctly implemented, as these differ from the specifications of the EU declaration of conformity. For example, the harmonized testing standards under RED will be adopted, but they will be listed as “BS (British Standard) EN” standards for the UK market in the future.

Currently, these standards are still those adopted by ETSI, but it can be assumed that the development will diverge in the future.

It is therefore urgently recommended to have a look at the exact requirements together with us, as these can differ from product to product – depending on the application and time.

The role of a UK Market Conformity Assessment Body (UKMCAB)

Where mandatory third-party conformity assessment was required for CE marked goods, it is also required for UKCA marked goods.

This conformity assessment must be carried out by a UK recognized conformity assessment body – a UK Market Conformity Assessment Bodies (UKMCAB) in order to be UKCA marked. The type of conformity assessment procedures is the same as that required for CE marking.

It should be noted that EU Notified Bodies cannot perform conformity assessment to UKCA specifications. Here, the involvement of a UKMCAB is required.

Of course, the UKCA certification also offers the possibility of a self-declaration – in this case UK self-declaration. Here, the procedure is analogous to the previous procedure for CE marking. If you include a UKMCAB, this is jointly responsible for the approval of the product.

Special case: UKCA approval for spare parts

Spare parts, for which no separate approvals are required, are exempt from the UK approval process according to the current status. New developments and series products must fully comply with the requirements of the UK approval after January 1, 2022. It is irrelevant whether products of a product series were already on the market before January 1, 2022:

  • Each individual product of a product series must comply with the UK requirements when placed on the market after January 1, 2022. If non-harmonized radio standards are used, a UKMCAB must also be involved.

The UKCA label

UKCA Label

By January 1, 2022 at the latest, the UKCA label must be used on products. The UKCA labels may only be applied to a product by you as the manufacturer or your authorized representative in the UK (if provided for in the relevant legislation).

Basic instructions for the use of the UKCA label:

  • UKCA labels may only be affixed to a product by you as the manufacturer or your authorized representative in the UK (if provided for in the relevant legislation).
  • When you affix the UKCA label, you accept full responsibility for ensuring that your product complies with the requirements of the relevant legislation.
  • You may only use the UKCA marking to demonstrate product conformity with the relevant UK legislation.
  • You must not affix any markings or signs that could misinterpret the meaning or form of the UKCA marking to any third party.
  • You must not affix any other markings to the product that affect the visibility, legibility or meaning of the UKCA marking.

For products that fall within the scope of, for example, the UK counterparts of the European Directives RED, EMCD as well as LVD, the marking must be on the product.

The UKCA marking is at least 5 mm high – unless another minimum dimension is specified in the relevant legislation. If the size of the UKCA marking is reduced or increased, the letters making up the UKCA marking must be proportional.

  Type of product Accepted labels or combinations thereof
Distribution of goods in Great Britain Produced goods that will be placed on the market in GB by the end of 2021 UKCA or CE
Distribution of goods in Great Britain Produced goods placed on the market in GB on or after January 1, 2022 UKCA

The special case of Northern Ireland

The UKCA designation is not recognized in Northern Ireland. The Northern Ireland Protocol entered into force on January 1, 2021. As long as it is in force, Northern Ireland will comply with the relevant EU rules for placing industrial products on the market.

Products that currently require CE marking for sale in the EU will continue to require CE marking for Northern Ireland.

However, manufacturers may have to follow different requirements for market approval in Northern Ireland:

  • You must use a conformity marking when placing certain goods on the Northern Ireland market.
  • In Northern Ireland, EU conformity markings continue to be used to show that goods comply with EU regulations.
    For most manufactured goods, this is the CE marking, but there are some other markings for certain products (for example, the wheel mark or the Pi mark).
  • If you use a UK body to perform mandatory third-party conformity assessment, you must also affix a UKNI marking
    (“United Kingdom Northern Ireland”; sometimes referred to as the UK(NI) marking or UK(NI) statement).
  • The UKNI marking is never affixed alone, but always in conjunction with an EU conformity marking, such as the CE marking.
    Goods bearing both the CE and UKNI markings may not be placed on the market in the EU.
  • You do not need to make any changes if both of the following apply:
    • You are a manufacturer (or the manufacturer’s authorized representative) located in Northern Ireland.
    • You currently mark your goods on the basis of a supplier’s declaration of conformity, sometimes referred to as a “self-declaration”.

When should you use the CE marking?

You can affix the CE marking to your goods when any of the following apply:

  • You are currently affixing the CE marking on the basis of a self-declaration, as required by the relevant product regulations.
  • A required third-party conformity assessment has been performed by a notified body recognized by the EU
    (including a body in a country with which the EU has an appropriate mutual recognition agreement).
  • Under these circumstances, goods bearing the CE marking may be placed on the market in NI and in the EU.

How can you use the CE marking or when must you use the UKNI marking alongside the CE marking?

You must use the UKNI marking (alongside the CE marking) when all of the following apply:

  • You place certain goods (mostly those subject to CE marking) on the Northern Ireland market.
  • Your goods require mandatory third-party conformity assessment.
  • You plan to engage a UK body to carry out these conformity assessments.

You cannot use the UKNI marking if any of the following apply:

  • You place goods on the market in the EU.
  • You plan to commission an EU body to carry out the mandatory third-party conformity assessment.

Requirements for the use of the UKNI label

  • The UKNI label may only be affixed to a product by you, the manufacturer, or your authorized representative (if required by the relevant legislation).
  • If you affix the UKNI label together with any other conformity marking, you assume full responsibility for ensuring that your product complies with the requirements of the relevant legislation.
  • You must not affix any markings or signs that could misinterpret the meaning or form of the UKNI marking to third parties.
  • You must not affix any other markings to the product that affect the visibility, legibility or meaning of the UKNI marking.
  • The UKNI marking must accompany any other conformity marking. It never appears alone on a product.

Our services

During the transition phase, we offer you as usual all tests and approval services for CE marking and thus for market approval in the United Kingdom.

  • If you wish to obtain UKCA certification already during the transition phase, you are also at the right address with us.
  • Together with you we will work out the right strategy for your approval process for the United Kingdom – completely individually adapted to your product.

We are currently in coordination with the German Accreditation Body (DAkkS) regarding the official accreditation of the BS EN standards. This will be the case shortly, so that we can carry out the tests according to the BS EN standards in a timely manner. Please already contact us now.

Due to the missing MRA between the EU and UK it is currently not possible for us to provide a UKMCAB. However, in order to be able to offer you this service as well, we have access to our extensive partner network.

Thus, we can offer you any form of market authorization for the United Kingdom – completely individually and from one source.
You can also find more information about UKCA certification in the associated webinar, which we held at the beginning of January 2021.

Frequently asked questions about UKCA marking

The CE mark remains valid in the UK until the end of 2021, from when should a changeover to the UKCA mark be made for goods to the UK?

At the latest by December 31, 2021, which is when the transition period ends.

What should a "Declaration of Confomity" look like? Which prefixes should e.g. standards and directives (e.g. EMC directive) have, which are referred to in a declaration of conformity?

The DoC is attracted in section 41 in the EMC Regulation 2016. This looks comparable to the CE Declaration of Conformity:

  • your name and full business address or that of your authorised representative
  • 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
  • your name and signature
  • the date the declaration was issued
  • supplementary information (if applicable)

Are EU standards and directives transferable 1:1 to "BS standards" and directives and vice versa? Which sources can be referred to here?

In the course of the transition, the standards are identical, except for terminology. Of course, reference is made to the fact that the standards are to be used for the presumption of conformity in accordance with British legislation. The directives are very similar. Again, it is primarily terminology that differs. The sources to be consulted are the Health and Security Executive in the UK: https://www.hse.gov.uk/index.htm

Is the additional involvement of a NB in the case of a declaration of conformity for non-harmonized standards the only additional effort in the future to obtain the UK declaration of conformity? If not, where else is further effort to be expected?

You have to show reports with BS EN standards if you want to put them on in the DoC. A list of “designated standards” for various regulations can be found here:
https://www.gov.uk/guidance/designated-standards#references-of-designated-standards

What will be the standard lead times until the declaration of conformity is received from the NB in the UK?

It is estimated that there will initially be somewhat longer lead times, as all bodies must first get used to the new processes.

What is the procedure for products already approved for the EU that have been tested and approved according to the ETSI standards? Do new measurements have to be made for all these products according to the BS standards to obtain approval in the UK?

Not necessarily, if the laboratory that performed the previous tests also has the BS EN standards in accreditation and is able to issue the test reports again to the BS EN standards.

Is there an "OJEU" for UK (overview of applicable standards)? What is the name of the RED for UK? What is the RoHS?

Yes, there is: https://www.gov.uk/guidance/designated-standards#references-of-designated-standards

RED: Radio Equipment Regulations 2017
RoHS: RoHS Regulations 2012

Is it correct that ATEX or radio products from 1.1.22 now need a country approval for UK and the approval of an EU NB according to EU directives / standards is no longer valid?

Yes. Also for the ATEX directive there is an equivalent according to UK legislation. Equipment and Protective Systems Intended for use in Potentially Explosive Atmospheres Regulations 2016. Here too, the UKMCAB acts as the certifying body.

What must the UKCA declaration in the operating instructions look like?

This can be found in the respective regulation, but is primarily very comparable to the CE declaration, but the terms from the UK regulations must be applied:

  • your name and full business address or that of your authorised representative
  • 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
  • your name and signature
  • the date the declaration was issued
  • supplementary information (if applicable)

Please show the UKCA approval process to a. new developments, b. serial products, c. spare parts after 01/01/2022.

Spare parts for which no separate approvals are required are currently excluded from the UK approval process.

New developments and series products must fully comply with the requirements of the UK approval after January 1, 2022. It does not matter whether products of a product series were already on the market before 01/01/2022: Each individual product of a product series must comply with the UK requirements when placed on the market after 01/01/2022.

When using non-harmonized radio standards, a UK CAB must also be involved.

UKCA mark on all new parts (newly homologated) from 01/01/2021 and on all existing parts. What is the role of 01/01/2023?

From 01/01/2023, the UKCA mark must be permanently affixed so that it cannot be removed under normal circumstances without leaving traces.

See also the requirements, in the so-called Blue Guide (chapter 4.5.1.4) for CE marking.

What about the ROHS exemptions (e.g. 6a and 6c)?

Requirements as well as exemptions can be found here: https://www.gov.uk/guidance/rohs-compliance-and-guidance

If necessary, exceptions must be specifically requested (ROHS@defra.gov.uk)

Do accessories (e.g. power supplies) also have to be marked with the UK label? Is a special approval necessary?

The same applies here as for the end product. The power supply can also be used for other devices, so it needs its own approval.

Where can specific requirements be found that go beyond the wording of the law? E.g. references to standards?

What exactly will be the 'nomenclature' of the standards? Also, it would be interesting to know how you see this, who can/must sign the UK DoCs. There are also various discussions and interpretations here.

The manufacturer/marketer must sign the DoC. The nomenclature is BS EN, BS IEC, BS ISO, etc. – BS ETSI does not exist. The issuer is BSI (British Standards Institution) in the UK.

What is the procedure for CE certification according to OEM standards? Will the OEM standards also be accepted in the UK (as with RED)?

That will depend on whether the referencing standards in the OEM standard contain the BS EN standard references. The European references are included, the BS EN must be added.

Are there any changes regarding the EU eCall?

Yes, there are. Here, too, there are ETSI standards behind it, which will certainly also be adapted, even if we cannot currently provide any more detailed information on this.

Are there special requirements for RFID systems for the frequency band 13.56 MHz (EN 300 330)?

No, the standard is adopted for the UK in the same way as other radio standards.

Does the UKCA label necessarily have to be on the product, or is it also sufficient on the packaging and/or operating instructions?

This depends on the regulations that apply to the product. For example, for products that fall within the scope of the UK counterparts of the European directives RED, EMCD and LVD, the marking must be on the product.

Placing on the market: For series products, what is placing on the market?

Placing on the market always refers to a single product (of a series). At the time of placing each individual product on the market, the current requirements or regulations must be met.

What is the role of the OEM/importer or the manufacturer? Who must be on the label?

The (legal) person who signs the declaration of conformity and thus bears the responsibility for placing the product on the market must put his name and address on the label (this is usually the manufacturer if the product is to be marketed under his name). This requirement also applies to importers.

With existing RED radio certification, does Bluetooth radio certification need to be re-done in the UK?

In case of doubt not at all, if the testing laboratory has also accredited the BS EN standards and can reissue the report to the new standards.

How is the transfer of existing EU RED certifications to the UKCA done? What is necessary and what does the process look like?

There is no pure transfer. You have to show that you have a product that meets the requirements of the UK regulations. This includes the use of the standards harmonized in the UK.

What happens if an EU NB continues to be commissioned with the declaration of conformity, must a NB in the UK then be commissioned in parallel for the declaration of conformity in accordance with the UKCA?

Currently yes, as the MRA between EU and UK is not in force.

Can products with only CE marking be sold in the UK from 01/01/2022 if they are already sold there?

Products that are placed on the market for the first time after 01/01/2022 must have the UKCA marking (possibly also in addition to the CE marking). The placing on the market does not refer to a type of product (which, for example, was already on the market before 01/01/2021), but always to a single product, regardless of whether it was manufactured as a single item or in series!

If I launch a product in the UK now, do I have to use UKCA labeling from 01/01/2022?

Yes.

Is the UKCA label already required when goods are sent from company location Germany to company location UK?

Depends on the further use. If the manufacturer sells here to end customers in the UK, it must be on it, if a distributor is in between, it can be delegated. But it must be legally secured so that customs accepts it.

What is additionally required for radio modules tested and certified by CETECOM?

Test reports according to BS EN. Then it depends on whether purely harmonized standards (according to UK directives) were used, or other standards. If non-harmonized standards are used, a UKMCAB is required.

What are the implications of Brexit for the UK in CENELEC? The question refers to the voting of UK in CENELEC esp. on EU matters (e.g. standardization mandates)?

The British Standards Institution (BSI) is still a member of CEN/CENELEC until 12/31/2021. During this transition period, the future status regarding BSI’s membership will be negotiated.

For CENELEC standards, will the UK's participation and voting rights change in light of Brexit and in particular with respect to standards developed under EC mandate?

The British Standards Institution (BSI) is still a member of CEN/CENELEC until 12/31/2021. During this transition period, the future status regarding BSI’s membership will be negotiated.

Does it mean that UK will no longer be in ETSI or will they base their standards on ETSI with national variations?

The British Standards Institution (BSI) will participate in ETSI – only their voting status has been moved to the non-EEA category.

Why are BS EN standards required in DAkkS accreditation, as BS EN standards are based on the EN version and include the UK national deviations?

In Germany, DAkkS accredits the standards under 17025 for the laboratories. This also applies to the BS EN standards. It is to be expected that the BS EN standards will differ in the future, even if this is currently only a guess.

What other measures (beyond labeling) are required when a CE certified product is accepted into the UKCA?

Test reports to BS EN standards are required, as is the use of a UKMCAB if non-harmonized radio standards are used.

Can I continue to import and sell products within 2021 with CE marking only or should I quickly start the process for UKCA?

CE marking may only be used until the end of 2021, so a UKCA certification is strongly recommended.

If the customs clearance is done by a non-UK company using the UK VAT number, who is the importer?

Under UK regulations, the importer is a person or company based in the UK. Therefore, non-UK companies cannot act as importers.

Are the UKCA requirements for radio equipment different from EU RED? Can test results be used?

At the moment this can be done as we have no more differences than terms. Later this can not be guaranteed.

Do manufacturers need to update their EU Type Examination Certificate for telecommunications equipment that complies with the RED?

No, as long as they do not intend to market their equipment in the UK.

What are the direct consequences of Brexit in terms of certification of products from the UK?

The situation here is that the former EU NBs in the UK are no longer authorized to issue type approval tests and EU NBs outside the UK must be used.

Must the UK importer be indicated on the product label?

The importer must include his name, registered trade name or trademark and a postal address where he can be contacted on the radio. If the importer is unable to place this information on the product itself due to the size or nature of the device, he may place it on the packaging or an accompanying document.

Will retesting of existing equipment be required?

Not mandatory, as this depends on the standards used. Currently it is possible to use BS EN standards provided that the laboratory is accredited for them.

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