This guidance covers the status of conformity assessment bodies if there’s a no-deal Brexit.
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The UK will leave the EU on 31 October. This page tells you how to prepare for Brexit. It will be updated if anything changes, including if a deal is agreed.
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This guidance is for:
- UK notified bodies
- recognised third-party organisations (RTPO)
- user inspectorates (UI)
- technical assessment bodies (TAB)
Collectively these are referred to as ‘conformity assessment bodies’.
For the purposes of this guidance, this term does not include any other types of conformity assessment body. This page covers conformity assessment activity mandated in the EU legislation listed below.
Actions for conformity assessment bodies
You do not need to take any action, unless you decide to cease operating before Brexit.
Legal framework for UK conformity assessment bodies
If there’s a no-deal Brexit, UK conformity assessment bodies will no longer be recognised as competent to carry out mandatory conformity assessment processes for products due to be placed on the EU market.
This does not apply to product testing where manufacturers voluntarily choose to contract out testing against European or international standards.
The government is putting in place a domestic legal framework that will enable UK conformity assessment bodies to continue operating for most products being placed on the UK market.
The UK product safety 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 medical devices and transportable pressure equipment) will automatically have their status converted under the new UK framework.
UK-based accredited notified bodies will automatically become UK approved bodies, and 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 conformity assessment statuses will be automatically converted by the government unless you decide to cease operating before Brexit. If you no longer intend to carry out conformity assessment, decide to cease operating, or change the scope of the services that you offer, you will need to follow the usual procedures.
In most cases, this means informing the United Kingdom Accreditation Service (UKAS), who will then inform the relevant government department.
If you choose to cease providing services under any particular area of legislation, you will be asked to either retain the relevant documents, transfer them to another body, or provide them to the relevant government department.
Database for UK conformity assessment bodies
The government is setting up a new domestic UK database to replace the EU’s New Approach Notified and Designated Organisations (NANDO) database. You can check your current company details on the NANDO database.
Updated letters of appointment or designation will be sent out soon after 31 October to confirm your new status and the conditions attached to your appointment. UKAS will also update your schedules of accreditation as needed.
You do not need to wait for receipt of a letter of appointment or designation to be able to carry out conformity assessment for the UK market.
You will also be able to apply the new UKCA marking to products. Find out more about the UKCA marking.
Converted UK bodies will also, subject to obtaining any additional accreditation necessary, be able to assess the conformity of products for export to third countries where the UK has secured ongoing mutual recognition of conformity assessment.
Any certificates you issued 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.
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.
The EU’s position is that 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.
Medical devices and transportable pressure equipment
Due to the complexity of the regulation, these products will not be subject to the new UK framework, and separate arrangements will apply.
If you carry out notified body activities for medical devices, please contact the Medicines and Healthcare products Regulatory Agency (firstname.lastname@example.org).
UK notified bodies would retain a legal status in the UK meaning all existing product certificates would remain valid for medical devices on the UK market. Find out more on regulating medical devices if there’s a no-deal Brexit.
Transportable pressure equipment (TPE)
Government will be revising the The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2009 later this year.
For further questions contact email@example.com.
EU legislation in the scope of this guidance
- 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)