current language
MAS available in the following languages:
or select your TÜV Rheinland region / country website:
British Flagg that symbolizes the leaving of UK from the EU

UKCA – Impact of UK Legislation on Market Access

Open the doors to the United Kingdom

Manufacturers and retailers who want to, or already do, market their products in the United Kingdom have seen countless changes since the UK left the EU. They had to navigate in a very dynamic legal environment that still has not settled down.

Since 2021, many product groups are subject to new legislations, which requires mandatory third-party conformity assessment and the UKCA marking. The transition period is still running and was extended for many products until end of 2024 (status: Nov. 2022). There are some exceptions and requirements to consider.

On this website, we inform you about legal changes, answer the most important questions and show you how we can support you in accessing the UK market.

Although the transition periods are still running, we recommend you to contact an experienced professional such as TÜV Rheinland to support you with your export plans. TUV Rheinland UK Ltd. is a UK Approved Body for a number of regulations, e.g. concerning Machinery, Pressure-, Radio- or Personal Protective Equipment, Toys and many more. As an expert in conformity assessments, we offer comprehensive support and tailored solutions to ensure that your products meet the requirements of the UK market.

Our experts work closely with you to understand your unique requirements and provide you with the best possible service. We are able to assess you technical documentation, conduct testings and certification and help you understand the complex requirements of UKCA compliance.

Rely on TÜV Rheinland as your UK Approved Body for UKCA conformity assessment and benefit from our proven expertise, global network and excellent reputation. Contact us to learn how we can help you access the UK market and increase your competitiveness.

News: British Department for Business and Trade (DBT) intends to continue CE recognition

British Department for Business and Trade (DBT) intends to continue CE recognition

In the UK market, the legal requirements for products that fall under the remit of the British Department for Business and Trade (DBT) could soon change. The Department has now announced that it intends to continue the recognition of the CE marking in its 18 existing regulations for an indefinite period!

The following three regulations do not fall within the scope of the Department but are also under discussion:

  • Ecodesign for Energy-Related Products Regulations 2010
  • The Explosives Regulations 2014
  • The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012 (‘The RoHS Regulations’)

With regard to RoHS, manufacturers should be able to apply two possible solutions: If products comply with the limit values according to EU regulations (Annex II to the EU RoHS Directive (2011/65/EU)), the CE marking is accepted. If manufacturers apply a derogation to their product, the CE marking applies if there is an equivalent derogation under the GB RoHS regulations.

This announcement does not apply to regulations for medical devices, construction products, marine equipment, rail products, cableways, transportable pressure equipment and unmanned aircraft systems regulations. There are specific arrangements in place for these sectors.

More legal certainty this spring

The ministry has indicated that they are aiming for a legally secured regulation this spring. Manufacturers and importers can also look forward to planned simplifications to the labelling regulations. Government announced greater labelling flexibility, including the voluntary option for digital labelling. We expect further information about it.

We know that many manufacturers struggle with the complex regulations and regular changes in UK legislation. Our experts are always available to answer your individual questions.

News: TÜV Rheinland is now a UK Approved Body according to UK MDR

Medical devices and the UK flag, symbolizing the certification for the UK market with UKCA.

We are pleased to announce that TUV Rheinland UK Ltd., as a reputable company, is now officially a UK Approved Body under the UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR). This recognition enables us to test and certify medical devices to ensure their compliance with UK requirements.

Thus, we offer comprehensive testing and certification services from a single source. Thanks to our many years of experience and our commitment to the highest quality standards, our team of experts is competent to provide testing and certification services to different regulations, including UK MDR.

Our UKCA services

UKAS, the national accreditation body for the United Kingdom, already recognized us to perform certifications according to various standards for several product groups.

The transition period – Update from November 14, 2022

Per announcement from UK government, CE mark will continue to be recognized in the UK for another two years (until the end of 2024). During this time, both UKCA or CE mark may be used. Different rules will apply for medical devices, construction products, cableways, transportable pressure equipment, unmanned aircraft systems, rail products, and marine equipment.

Which consequences occur?

The government also declares to reviewing the wider product safety framework and prove further methods like e-labelling. Until 31 December 2027, the government will allow to affix the UKCA marking and include importer information for products from EEA countries on an accompanying document or label. Until this date, CE conformity assessment activities can also be used as the basis for the UKCA marking, when carried out before 31 December 2024.

What´s behind the change?

The decision is meant to provide relief to business costs for retesting and labelling and to allow them to focus on growth instead, considering the current difficult economic conditions.

For more information, please see the UK government website.

EU Regulation UK Regulation (UKAS and MHRA)
Medical Devices Regulation - 2017/745 (MDR)
In Vitro Diagnostics Regulation - 2017/746 (IVDR)
Medical Devices Regulations 2002
(The following EU Directives are given effect in UK law through the MDR 2002: Directive 93/42/EEC (medical devices), Directive 90/385/EEC (active implantable), and Directive 98/79/EC (in vitro diagnostics))

Benefit from a seamless certification process

Our UKCA experts will guide you through the entire certification process to ensure that your products meet the UK standards and comply with all required regulations. We work efficiently and expeditiously to complete your certification as quickly as possible for your seamless market entry.

Our self-serve information webinars for you

On-demand webinar: UKCA for Machinery

On-demand webinar: UKCA for Machinery

Open the doors to the United Kingdom with UkCA certification of Machinery. Register now!

On-demand Webinar: Impact of BREXIT


What to do, How to do it, When to do it!

Show all Hide all

Do I need a UK adress on the product, if I import from the EU?

Yes, the importer address should also be placed on the product. The legislation specific to your product may make allowances for the importer details to be placed elsewhere if it is not practical to place them on the product.

When does the UKCA mark have to be displayed, and where?

From January 1st 2023, the UKCA mark will be required to be displayed on products (except for medical devices - CE marking will continue to be recognized until June 31st 2023). To reduce the impact on businesses, the UKCA mark can be affixed optionally to the product or an enclosed document using a label. This will be accepted until December 31st 2022 only. After this time, the UKCA mark must be affixed directly to the product (unless the applicable regulations make other allowances).

Existing stocks that were fully manufactured and conformity marked prior to January 1st 2023 can still be placed on the British market after January 1st 2023 with a CE-marking and, where appropriate, the number of the Notified Body.

For the CE mark in 2021, can the EU representative listed in the DOC live in UK or must reside in the other 27 states? Currently our EU rep lives in UK.

An EU representative must be located in the EU, UK based representatives will no longer be recognised as an EU representative after 31st December 2020.

Is there a possibility that “Approved Bodies“ will not be authorised in time for all the relevant regulation areas (for UKCA conformity assessment)? Are there other Approved Bodies in the UK, or will be?

Any EU Notified Bodies located within the UK will automatically become UK Approved Bodies on 1st January 2021 so we can be confident that the vast majority of the total scope will be covered by a UK Approved Body. That said there is a risk that for a few products no UK Approved Body will have them on their scope before the end of the transition period, in which case the relevant authority should be contacted for advice.

May I continue using certificates issued by British Notified Body, but for the European Union ?

Under European Union product legislation, Notified Bodies must be established in an EU Member State and must be designated by a competent authority of a Member State in order to perform activities as part of a conformity assessment.

With the loss of “EU status” for many Notified Bodies, as of January 1st 2021, British Notified Bodies based in Great Britain are no longer able to perform conformity assessment activities under European legislation, and as a result, certificates issued by such a Notified Body will not be valid going forward.

At this point, advice to companies is to switch to a Notified Body or type-approval authority located in the EU single market if they wish to continue to market their products and vehicles in the European Union.

Are test reports issued within EU, accepted by UK to certify products in line with UKCA?

Where third party conformity assessment is required by the applicable legislation, test reports issued outside of the UK may be accepted by a UK Approved Body at their discretion for certification. This is only possible if the testing laboratory holds suitable accreditation and the correct test standards were applied.

I was under the impression that CE and UKCA are self-certification. Has this changed? What would be the reason to ask a notified body to look over anything apart from peace of mind? If the testing performed meets standards used in that market don’t you just fill out a Declaration and save the results like we used to? (and register the product).

For many Directives/Legislation no Notified Body/Approved Body involvement is required, however some Directives/ Legislation do require the involvement of a Notified Body. The UKCA requirements very closely mirror the CE requirements, so if you do not require the involvement of a Notified Body for your CE you will not need a UK Approved Body for UKCA.

Is there a gap analysis between the EU and UK regulations?

There is no gap analysis as such but the linked document below shows many of the changes that were made to the directives to make them UK legislation as a result of Brexit:


pdf Requirements for Toys in UK 312 KB Download
pdf Certification scheme description - Lifts Regulations 527 KB Download
pdf Certification scheme description - Pressure Equipment Regulations 429 KB Download
pdf UK Legislation Impact FAQ 340 KB Download
pdf Testing and Certification Regulations (PZO) of TÜV Rheinland UK Ltd. (TRUK) 175 KB Download


Please contact us for more information!

Please contact us for more information!

Request a Quote