The abbreviation UKCA stands for UK Conformity Assessed. The UKCA label is a prerequisite for marketing products within the United Kingdom. In the context of the Brexit, it replaces the CE marking previously used for this region, which can still be used until December 31, 2022.
In February 2020, the decision was made that the United Kingdom will leave the EU. This step was completed on 01.01.2021, 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,
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 are already in circulation in the UK before 01.01.2021 and were thus imported, remain valid and the products can still be sold in the UK. This is where grandfathering applies.
Manufacturers can usually provide evidence of placing on the market using any relevant document commonly used in commercial transactions, including
For manufacturers wishing to authorize products for the UK after 01/01/2021, there are two options for market authorization:
Important: The relevant economic operator (whether manufacturer, importer or dealer/distributor) bears the burden of proof that the goods were placed on the market before January 1, 2021.
This also includes the consideration of modified safety and import regulations, which may vary from industry to industry (e.g. medical devices).
The UKCA approval is already valid from 01.01.2021 and can be used for market approval for the UK.
The UK authorities confirmed in July 2022 that, for the purpose of obtaining a UKCA mark, all EU type examination certificates issued by notified EU bodies before 01 January 2023 will now be recognized until 12 December 2027.
Despite the transition period granted by the UK authorities, 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 that CE marking of medical devices in the UK will continue to be recognized until June 30, 2023. This also includes medical devices with radio functions.
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 obtain 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 here 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.
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 nature of the conformity assessment procedures is the same as that required for CE marking.
It should be noted here that EU Notified Bodies cannot perform conformity assessment to UKCA specifications. Here the involvement of a UKMCAB is required. Here, too, cetecom advanced is the right partner for you – with our internal UKMCAB.
Of course, the UKCA certification also offers the possibility of a self-declaration – in this case UK self-declaration. Here it runs analogous to the previous procedure for CE marking. If you involve a UKMCAB, this is jointly responsible for the approval of the product.
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, 2023. It is irrelevant whether products of a product series were already on the market before 01.01.2023:
By 01/01/2023 at the latest, the UKCA label must be used on products. The 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).
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 shall be at least 5mm high – unless a different 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.
The UKCA marking 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 may affix the CE marking to your product if any of the following apply:
You must use the UKNI marking (alongside the CE marking) if all of the following apply:
You cannot use the UKNI marking if any of the following apply:
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.
In addition we can fall back on the services of our internal UKMCAB.
Thus we can offer you any form of market approval for the United Kingdom – completely individually and from one source.
At the latest by December 31, 2022, which is when the transition period ends.
The DoC is attracted in section 41 in the EMC Regulation 2016. This looks comparable to the CE Declaration of Conformity:
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 relevant sources are the Health and Security Executive in the UK: https://www.hse.gov.uk/index.htm
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
It is estimated that there will initially be somewhat longer lead times, as all bodies must first get used to the new processes.
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.
Yes, there is: https://www.gov.uk/guidance/designated-standards#references-of-designated-standards
RED: Radio Equipment Regulations 2017
RoHS: RoHS Regulations 2012
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.
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:
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, 2023. It does not matter whether products of a product series were already on the market before 01/01/2023: Each individual product of a product series must comply with the UK requirements when placed on the market after 01/01/2023.
When using non-harmonized radio standards, a UK CAB must also be involved.
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.
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)
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.
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.
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.
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.
No, the standard is adopted for the UK in the same way as other radio standards.
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 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.
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.
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.
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.
Currently yes, as the MRA between EU and UK is not in force.
Products that are placed on the market for the first time after 01/01/2023 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!
Yes.
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.
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.
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.
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.
The British Standards Institution (BSI) will participate in ETSI – only their voting status has been moved to the non-EEA category.
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.
Test reports to BS EN standards are required, as is the use of a UKMCAB if non-harmonized radio standards are used.
CE marking may only be used until the end of 2022, so a UKCA certification is strongly recommended.
Under UK regulations, the importer is a person or company based in the UK. Therefore, non-UK companies cannot act as importers.
At the moment this can be done as we have no more differences than terms. Later this can not be guaranteed.
No, as long as they do not intend to market their equipment in 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.
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.
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.
