Guidance Documents: Conformity Assessment After BREXIT

TIC Council

Guidance Documents: Conformity Assessment After BREXIT

From 1 January 2021, the UK government is putting in place a domestic legal framework that will allow UK conformity assessment bodies (CABs) to continue operating for most products being placed on the Great Britain (GB) market. The new UK domestic regime will cover most goods currently subject to the EU’s CE marking. While the technical requirements for these goods will be the same on 1 January 2021 as they are now, there will still be certain changes, including the introduction of the UKCA marking and a system of third-party conformity assessment by UK-recognised approved bodies, in place of the current EU system of notified bodies.

From 1 January 2021:
 

  • A new legal framework will allow UK CABs to continue operating for most products being placed on the market in GB (England, Wales and Scotland).
  • Most conformity assessment bodies in the UK 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 the national accreditation body (where relevant).
     

There will be a ‘standstill period’ which for most goods will last from 1 January 2021 the 31 December 2021. During this time businesses are encouraged to be ready for full implementation of the new UK regime as soon as possible after 1 January 2021. However, to allow businesses time to adjust, CE marked goods in scope of this guidance that meet EU requirements (where these match UK requirements) can continue to be placed on the GB market until 1 January 2022 where EU and UK requirements remain the same. This includes goods which have been assessed by an EU recognised notified body.

These transitional measures will only apply until the 1 January 2022. From this point the UKCA mark will be required to be displayed on products, where the CE mark is currently used, to show compliance to the UK domestic regime. To ease the burden on businesses, until the 1 January 2023 for most goods covered by UKCA marking, there will be the option to affix the UKCA marking on a label affixed to the product or on an accompanying document. The economic operators (whether manufacturer, importer, or distributor) should take reasonable steps to ensure the UKCA marking remains in place. From 1 January 2023, the UKCA marking must, in most cases, be affixed directly to the product. The UK representatives emphasized that CAB’s should plan early for the new UK regime and not wait until the end of 2021 to start preparing.

This guidance relates primarily to goods regulated by the Department for Business energy and Industrial Strategy (BEIS) under the areas listed in the guidance. This guidance does not wholly apply to medical devicesrail interoperabilityconstruction products and civil explosives; goods regulated under the old approach (chemicals, medicines, vehicles and aerospace) and goods covered by national rules (see the UK specific rules guidance for more information).

UK officials have published four main documents on guidance:

1. Placing UKCA and CE marked goods on the GB market from 1st January 2021.

2. Placing manufactured goods on the EU market from 1st January 2021.

3. Prepare to use the UKCA marking from 1st January 2021.

4. Conformity assessment bodies: status from 1st January 2021.

5. How the MHRA will manage orphan medicinal products from 1 January 2021 in Great Britain (GB)

For any further queries please contact us at secretariat@tic-council.org

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