Providing answers and insights into the UKCA mark
Providing answers and insights into the UKCA mark
Here you’ll find answers and insights to some of the most commonly asked questions relating to the subject of UKCA marking.
The UKCA (United Kingdom Conformity Assessed) mark is UK legislation which will replace the CE mark for placing products on the market in Great Britain (CE marking is still required in Northern Ireland). The UKCA mark will apply to most products, exceptions are for example Marine equipment where there is a proposed Marine UK mark replacement for the current Marine Wheel mark. Products being placed on the EU market will still require CE marking so that dual CE / UKCA marking may be required. UKCA marking applies to products that require mandatory third-party conformity assessment via a UK Approved Body (using for example conformity route Module B UK Type Examination) and products which can be self-declared (using for example conformity route Module A Internal Production Control)
There is a transitional period of acceptance of CE (and Wheel) marking in Great Britain until 1 January 2022 for most products, for Marine products until 1 January 2023 (for the Wheel mark) and for Medical products until 30 June 2023. These extensions are subject to the UK and EU legislation requirements still aligning during these periods. UKCA marking can be applied from 1 January 2021 and manufacturers are being encouraged to consider these requirements as soon as possible and engage with a UK Approved Body if applicable.
Whilst initially UKCA marking requirements will follow EU requirements with respect to EU harmonised standards for example there is a possibility that this will diversify in the future. Manufacturers will need to apply the UKCA mark to most products being placed on the market in England, Scotland and Wales which will demonstrate conformity to UK legislation (UK Statutory Instruments) and the associated essential requirements in this UK legislation. Manufacturers will additionally require a UK Declaration of Conformity which will need to list UK legislation (UK Statutory Instruments) and UK designated standards for compliance. For products and UK legislation that require a certification body, a UK Approved Body such as TÜV SÜD BABT will be required.
All UK based EU Notified Bodies became UK Market Conformity Assessment Bodies on the 1 January 2021 for their current scope of accreditation allowing UKCA certification work to commence immediately. The 4 digit notified body number has been retained, i.e. TÜV SÜD BABTs UK Approved Body Number 0168 has been retained. The EU NANDO Information System database has been updated to remove UK based Notified Bodies which means UK based Notified Bodies can no longer be used for EU/CE certification work. Note - TÜV SÜD BABT are still a “Notified Body” for Northern Ireland for CE+UKNI requirements if required.
As the EU – UK Trade deal excluded a Conformity Assessment Body Mutual Recognition Agreement (MRA) EU based notified bodies are not recognised as UK Market Conformity Assessment Bodies and cannot be used for UKCA marking.
Type Examination Certificates from a UK based Notified Body are no longer valid in the EU. To continue to place products on the EU market you will need to have your products certified by a Notified Body as listed on the EU NANDO Information System (which will be either based in the EU or via a Country which has an MRA with the EU).
TÜV SÜD have multiple Notified Bodies to support this activity.
With respect to existing products, the rules for the EU and UK are the same, that is that legislation applies at the point when the individual product is placed on the market. UKCA marking would not be required for products already placed on the market (already imported and with a distributor for example) prior to 1 January 2021 or longer depending on the acceptance period of the CE marking.
TÜV SÜD BABT has been appointed as a UK Market Conformity Assessment Body (UK Approved Body 0168) and can support your requirements immediately. The TÜV SÜD BABT scope of accreditation is also currently being extended for additional product types news of this will be published shortly.
Using the UKCA mark from 1 January 2021:
Regulating medical devices from 1 January 2021
Conformity assessment bodies change of status from 1 January 2021
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