UK Approved Bodies: A Complete Guide

Certain products can only be sold in the United Kingdom if a UK Approved Body (also known as UK Market Conformity Assessment Bodies) has been involved in the conformity assessment process. Such products include medical devices, PPE, and products belonging to other categories.

In this guide, we explain how you can find UK Approved Bodies, the tasks they carry out, and how much you can expect to pay. 

What is a UK Approved Body?

UK Approved Bodies are organisations authorised by the UK Government to carry out certain parts of conformity assessment procedures in order to assess if products meet certain requirements.

Many UK Approved Bodies specialise in specific areas. For instance, one may only assess personal protective equipment, while another may only handle measuring and weighing instruments. However, some UK Approved Bodies offer services that cover different product areas.

Here are some examples of companies that act as UK Approved Bodies taken from the GOV.UK:

• TIMESACE Limited
• Safenet Limited
• SGS United Kingdom Ltd
• DNV Business Assurance Ltd
• Lift Cert Limited

How to find a UK Approved Body

You can search for UK Approved Bodies on the GOV.UK’s “UK Market Conformity Assessment Bodies” (UKMCAB) page. In this example, we filtered for body type “Approved body” and legislative area “Electromagnetic compatibility”:

Filtering by body type

You can search for conformity assessment bodies by filtering between the following seven body types:

• Approved body
• NI Notified body
• Overseas body
• Recognised third-party
• Technical assessment body
• UK body designated under MRA
• User inspectorate

In the case of the above example, we filter for “Approved body”, as most UKCA marking regulations refer to an “approved body”, when a conformity assessment body is necessary. However, other regulations may require to use of a different type of body.

Filtering by Legislative area

You can also search for conformity assessment bodies by selecting the applicable legislative area (that is, product category).

The UKMCAB database lists the following legislative areas:

• Construction products
• Ecodesign
• Electromagnetic compatibility
• Equipment and protective systems for use in potentially explosive atmospheres
• Explosives
• Gas appliances and related
• Lifts
• Machinery
• Marine equipment
• Measuring instruments
• Medical devices
• Noise emissions in the environment by equipment for use outdoors
• Non-automatic weighing instruments
• Personal protective equipment
• Pressure equipment
• Pyrotechnics
• Radio equipment
• Railway interoperability
• Recreational craft
• Simple pressure vessels
• Toys
• Transportable pressure equipment

Filtering by UK body designated under MRA

According to GOV.UK, Mutual Recognition Agreements (MRAs) simplify the conformity assessment process for UK importers and exporters. For example, MRAs allow UK exporters to designate UK-based CABs to assess the compliance of their products against the regulations of the country where they intend to sell their products.

For example, under the UK-Canada MRA, UK exporters of electronics can use UK-based CABs to ensure compliance with Canadian electromagnetic compatibility requirements.

GOV.UK lists the following countries for which you can use a UK body designated under MRA:

• Australia
• Canada
• Japan
• New Zealand
• United States

Filtering by Registered office location

If you are overseas and looking at exporting to the UK, you can use the “registered office location” filter to find approved conformity assessment bodies in your country.

The UKMCAB page lists the following office locations:

• United Kingdom
• Australia
• Canada
• France
• Germany
• Hungary
• New Zealand
• Slovakia
• Switzerland
• United States

What do UK Approved Bodies do?

UK Approved Bodies perform specific conformity assessment procedure tasks. Here are some examples of tasks that a UK Approved Body may need to perform under the requirements of the Personal Protective Equipment Regulation (EU) 2016/425:

a. Type-examination (Module B, in Annex V):

• Examine the PPE’s technical design
• Examine the PPE’s technical documentation
• Verify the conformity of the specimen
• Perform tests and examinations
• Draw up an evaluation report
• Issue a type-examination certificate to the manufacturer
• Keep up to date on any changes to the approved type

b. Conformity to type based on internal production control plus supervised product checks at random intervals (Module C2, in Annex VII):

• Carry out random product checks
• Select a product sample, and test and examine it
• Verify the conformity of the PPE
• Issue a test report to the manufacturer

c. Conformity to type based on quality assurance of the production process (Module D, in Annex VIII):

• Assess the quality system to ensure the PPE’s conformity
• Evaluate any proposed changes and notify the manufacturer of its decision
• Authorise the manufacturer to affix the approved body’s identification number to each compliant PPE
• Perform periodic audits

Note that the tasks mentioned above are just examples from the Personal Protective Equipment Regulation (EU) 2016/425, and other conformity assessment tasks exist. Also, different regulations may require UK Approved Bodies to perform different conformity assessment tasks.

Which regulations require UK Approved Body involvement?

According to the GOV.UK’s guidance page for “UK conformity assessment”, there are 21 regulations that require you to use a UK Approved Body.

Keep in mind that a UK Approved Body may not be required in all cases. For example, under the Radio Equipment Regulations 2017, a UK Approved Body is only required when designated standards do not exist, or are not fully applied.

Here are the UK regulations that we could find for which you need to use a UK Approved Body (at least in some cases):

a. Toys (Safety) Regulations 2011

b. Recreational Craft Regulations 2017

c. Simple Pressure Vessels (Safety) Regulations 2016

d. Electromagnetic Compatibility Regulations 2016

e. Non–automatic Weighing Instruments Regulations 2016

f. Measuring Instruments Regulations 2016

g. Lifts Regulations 2016

h. Equipment and Protective Systems Intended for use in Potentially Explosive Atmospheres Regulations 2016

i. Radio Equipment Regulations 2017

j. Pressure Equipment (Safety) Regulations 2016

k. Regulation 2016/425 on personal protective equipment

l. Regulation 2016/426 on gas appliances

m. Supply of Machinery (Safety) Regulations 2008

n. Noise Emission in the Environment by Equipment for use Outdoors Regulations 2001

o. Boiler (Efficiency) Regulations 1993

p. Pyrotechnic Articles (Safety) Regulations 2015

q. Regulation (EU) 2016/424 on cableway installation

r. Merchant Shipping (Marine Equipment) Regulations 2016

s. Explosives Regulations 2014

t. Construction Products Regulations (Regulation (EU) 305/2011)

Note that more regulations requiring you to use a UK Approved Body may exist.

FAQ

Is it mandatory to involve a UK Approved Body?

You must use a UK Approved Body to assess your product’s conformity only if one or more UK regulations covering your product require it.

For example, the Personal Protective Equipment Regulation (EU) 2016/425 requires you to use a UK Approved Body to assess the conformity of products categorised into risk categories II and III (e.g. equipment that protects against electric shock).

Are UK Approved Bodies mandatory for all products in the UK?

No, you do not need to use UK Approved Bodies for all products. You must use them when regulations specifically require the performance of a conformity assessment by a UK Approved Body.

For example, you do not need a UK Approved Body for most textile products or furniture.

Are UK Approved Bodies mandatory for UKCA marked products?

No, not all products that require UKCA marking require the involvement of a UK Approved Body.

Can a UK Approved Body be located outside the UK?

Yes. For instance, SGS North America Inc. is located in Suwanee in the United States, and is marked as both an Approved body and an overseas body in the database.

We could not find the exact conditions for when a non-UK company can become a UK approved body. However, we suspect that the company must be located in a country that has signed a Mutual Recognition Agreement (MRA) with the UK.

Are EU Notified Bodies accepted in the UK?

You should generally use UK Approved Bodies for products sold in the United Kingdom. However, there are certain cases where you can use an EU Notified Body. In this case, you must affix the CE marking – instead of the UKCA marking.

The GOV.UK “CE marking” guidance page lists several regulations for which the CE marking can be used in the UK, instead of the UKCA marking. Here are some examples:

• Toys
• Gas appliances
• Personal protective equipment

How much do UK Approved Bodies charge?

The amount of money charged by a UK Approved Body depends on the body chosen by the manufacturer and the product under assessment. The cost also depends on what tasks the UK Approved Body must perform, which in turn depends on the requirements of the relevant conformity assessment procedure.

As such, the fees can range from a few hundred to tens of thousands of pounds for more complex products and procedures.

We suggest that you contact the UK Approved Body of your choice to get a quotation.

Note: Contains public sector information licensed under the Open Government Licence v3.0.