How conformity assessment bodies will be affected when the UK leaves the EU.
This guidance is only for:
- UK notified bodies
- recognised third-party organisations (RTPO)
- user inspectorates (UI)
- technical assessment bodies (TAB)
It applies to conformity assessment activity required by relevant EU legislation.
You do not need to take any action, unless you decide to stop operating before Brexit.
a new legal framework will allow you to continue operating for most products being placed on the UK market
most conformity assessment bodies will automatically have their status converted under the new framework
a new UK database will replace the EU’s New Approach Notified and Designated Organisations (NANDO) database
the United Kingdom Accreditation Service (UKAS) will continue as your national accreditation body
The new UK legal framework
After Brexit, UK conformity assessment bodies will no longer be recognised as competent to carry out mandatory conformity assessment for products being placed on the EU market.
This does not apply to product testing where manufacturers voluntarily contract out testing against European or international standards.
The government is putting in place a domestic legal framework that will allow UK conformity assessment bodies to continue operating for most products being placed on the UK market.
The new UK legal framework will mirror the existing EU framework as far as possible. The technical requirements for becoming a UK approved body or a UK-recognised RTPO, UI or TAB will be broadly the same as they are now.
Conversion to UK arrangements
Most conformity assessment bodies in the UK (excluding those for medical devices and transportable pressure equipment) will automatically have their status converted under the new UK framework.
UK-based notified bodies will become UK approved bodies, and UK-based RTPOs, UIs and TABs will become UK-recognised RTPOs, UIs and TABs respectively.
You do not need to take any action to be transferred under this arrangement. UK-based notified bodies who become approved bodies will keep the same 4-digit identification number as they have now.
Stopping operating or changing your services before Brexit
If you no longer intend to carry out conformity assessment, decide to stop operating, or change the scope of the services you offer, you will need to follow the usual procedures. In most cases, this means informing UKAS, who will then inform the relevant government department.
If you choose to stop providing services under any particular area of legislation, you will be asked to do one of three things with the relevant documents. They are:
- retain them
- transfer them to another body
- provide them to the relevant government department
Medical devices and transportable pressure equipment
These products will not be covered by the new UK framework.
If you carry out notified body activities for medical devices, contact the Medicines and Healthcare products Regulatory Agency by emailing firstname.lastname@example.org.
All existing product certificates will remain valid for medical devices on the UK market. Find out more on regulating medical devices after Brexit.
Transportable pressure equipment (TPE)
The government will revise The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2009 later in 2019.
UK replacement of NANDO database
The government is setting up a new domestic UK database to replace the EU’s NANDO database. You can check your current company details on the NANDO database.
Assessments can continue
Updated letters of appointment or designation will be sent out soon after Brexit to confirm your new status and the conditions attached to your appointment. UKAS will also update your schedules of accreditation as needed.
You can continue to carry out conformity assessments for the UK market. You do not need to wait until you get the letter of appointment or designation.
You will be able to apply the new UKCA marking to products.
Converted UK bodies will also be able to assess the conformity of products for export to third countries, subject to:
- the UK securing ongoing mutual recognition of conformity assessment
- getting any additional accreditation necessary
Any certificates you issue to your clients before the UK leaves the EU will continue to be valid for the UK market and will be treated as if they had been issued under the new UK framework. You do not have to reissue certificates.
Accreditation by UKAS
UKAS will continue as the UK’s appointed national accreditation body. Its role in accrediting UK approved bodies will be the same as its current role for UK-based notified bodies.
UKAS accreditation for appointment of conformity assessment bodies will no longer be valid under EU legislation. However, outside of relevant EU regulatory requirements UKAS accreditation will still be recognised and accreditation certificates will continue to be valid.
UKAS expects to continue its membership of the European Cooperation for Accreditation (EA) and will continue to provide accreditation of other types of assessment bodies (such as test houses and laboratories) against recognised international standards.
UKAS’s membership of the International Accreditation Forum (IAF) and the International Laboratory Accreditation Cooperation (ILAC) will be unaffected if there’s a no-deal Brexit.
If you have further questions contact email@example.com.
Relevant EU legislation
- Toy Safety (Directive 2009/48/EU)
- Transportable pressure equipment (Directive 2010/35/EU)
- Construction products (Regulation (EU) No 305/2011)
- Pyrotechnic Articles (Directive 2013/29/EU)
- Recreational craft and personal watercraft (Directive 2013/53/EU)
- Civil Explosives (Directive 2014/28/EU)
- Simple Pressure Vessels (Directive 2014/29/EU)
- Electromagnetic Compatibility (Directive 2014/30/EU)
- Non-automatic Weighing Instruments (Directive 2014/31/EU)
- Measuring Instruments (Directive 2014/32/EU)
- Lifts (Directive 2014/33/EU)
- ATEX (Directive 2014/34/EU)
- Radio equipment (Directive 2014/53/EU)
- Pressure equipment (Directive 2014/68/EU)
- Marine Equipment (Directive 2014/90/EU)
- Personal protective equipment (Regulation (EU) 2016/425)
- Gas appliances (Regulation (EU) 2016/426)
- Machinery (Directive 2006/42/EC)
- Interoperability of the rail system within the Community (Directive 2008/57/EC)
- European Electronic Toll Service and its technical elements (Directive 2009/750/EC)
- Outdoor Noise (Directive 2000/14/EC)
- Hot-water boilers (Directive 92/42/EEC)
- Appliances burning gaseous fuels (Regulation (EU) 2016/426)
- Active Implantable Medical Devices (Directive 90/385/EEC)
- Medical Devices (Directive 93/42/EEC)
- in vitro Diagnostic Medical Devices (Directive 98/79/EC)
- Medical Devices (Regulation 2017/745)
- in vitro Diagnostic Medical Devices (Regulation 2017/746)
- Ecodesign (Directive 2009/125/EC)