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This publication is available at https://www.gov.uk/government/publications/status-of-conformity-assessment-bodies-after-brexit/status-of-conformity-assessment-bodies-under-no-deal
This guidance refers to UK notified bodies, recognised third-party organisations (RTPO), user inspectorates (UI) and technical assessment bodies (TAB) collectively as ‘conformity assessment bodies.’ For the purposes of this guidance, this term does not include any other types of conformity assessment body. This guidance covers conformity assessment activity mandated in the EU legislation listed below.
Legal framework for UK conformity assessment bodies
If the UK leaves the EU without an agreed deal, the EU has made clear that UK conformity assessment bodies will no longer be recognised as competent to carry out conformity assessment processes for products due to be placed on the EU market.
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 and 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 of conformity assessment bodies
Most conformity assessment bodies in the UK (excluding Medical Devices and Transportable Pressure Equipment – see below for further detail) will automatically have their status converted by the government 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 the UK leaves the EU. 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.
New database for UK Market Conformity Assessment Bodies
The government is setting up a new UK database which will replace, for domestic purposes, the EU’s New Approach Notified and Designated Organisations (NANDO) database. You can check the details of your company which are currently published on the NANDO database.
Updated letters of appointment or designation will be sent out soon, if the UK leaves the EU without a deal, 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 in order to be able to carry out conformity assessment for the UK market. You will also be able to apply the new UK marking to products (or, where relevant, the UK replacement for the Wheel Mark).
Read the guidance on using the new 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. This means you do not have to reissue certificates, but your clients who continue to rely on a certificate you hold would need to use the relevant new UK conformity marking after exit day for products which are not ready for placing on the market immediately after the UK leaves the EU.
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. The UK government has confirmed that UKAS’ role as the national accreditation body including for most UK conformity assessment bodies will remain as it is now.
UKAS also expects to maintain 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’ membership of the International Accreditation Forum (IAF) and the International Laboratory Accreditation Cooperation (ILAC) will be unaffected if the UK leaves the EU without a deal.
Medical devices and transportable pressure equipment
Due to the complexity of medical devices 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). As detailed in the guidance on regulating devices in the event of a no deal 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.
In addition, the Department for Transport (DfT) intends to consult later this year with industry on the approach being taken on transportable pressure equipment (TPE). This will include whether a separate UK conformity mark for use in the domestic market should be introduced and UK notified bodies for TPE recognised as appointed or approved bodies listed on the new UK database. Responsibility for appointment of inspection bodies for transportable pressure equipment under the UN Agreements concerning the International Carriage of Dangerous Goods by Rail (RID) and by Road (ADR) is unaffected and remains with DfT.
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)