When does the UKCA mark become mandatory?
For most products the UKCA mark must be applied by 1 January 2025. For medical devices the requirement to apply the UKCA mark is not compulsory until 1 July 2023.
What do I do about products already manufactured before the January 2025 deadline but not yet sold?
Products already in the supply chain at the time the new rules come into force can continue to be sold under the old rules.
Can I sell products with the UKCA mark but not the CE mark in Northern Ireland?
No, Northern Ireland remains in the Single Market so the CE marking rules continue to apply there.
We have a product with a UKCA label and a CE mark. Will it also need a UKNI label if it is sold in Northern Ireland?
Not necessarily. The UKNI mark is only used when a product needs to have a Notified Body approval but the approval is done by a UK Approved Body.
Can products with a UKNI mark and a CE mark be sold outside Northern Ireland?
Yes, so long as they are qualifying Northern Irish goods they can be sold elsewhere in the UK, but not in the EU.
What are ‘qualifying Northern Irish Goods’?
‘Qualifying Northern Irish Goods' are goods which are legally entitled to be in free circulation in Northern Ireland.
I have a product with a CE mark which I am selling in Northern Ireland. Can I also sell it elsewhere in the UK?
Yes, but only until the end of 2024 (or 30 June 2024 if it is a medical device). After that you will need the UKCA mark to sell in Great Britain.
I have a UK Approved Body certificate for my product. Can I put the CE mark on it?
Yes, but you must accompany the CE logo with a UKNI marking and you can only sell the product in Northern Ireland.
Do all instructions for products sold in the UK have to be in English?
As a UK based manufacturer, beyond the end of 2024, can we still apply the CE mark to our product and sell it in Europe, or is that the responsibility of the importer?
Yes, you can continue apply the CE mark and to sell the products in Europe but you will need to appoint an Economic Operator based within the EU to provide a point of contact for the market surveillance authorities.
We manufacture class II medical devices in the UK. We have a Notified Body certificate that was issued in 2019 by a UK based notified body. Can we continue to CE mark our products and sell them in Europe and the UK?
No. All certificates issued by UK based Notified Bodies ceased to be valid on 1 January 2021. You need to contact the company that issued the certificate and ask them about getting it re-issued by a European office.
We manufacture Class I medical devices in our factory in Berlin and sell them in the UK. By what date do we have to put the UKCA mark on our products?
You can continue to sell properly CE marked medical devices into the UK without the UKCA mark until 30 June 2024.
I understand that certificates issued by UK Notified Bodies are invalid for CE marking from 1 January 2021. My product is certified by a Notified Body based in Italy. Do I have to get a certificate from a UK Approved Body in order to sell into the UK?
The UK will allow properly CE marked products to be placed on the market until 31 December 2024 (30 June 2024 in the case of medical devices). A certificate from a UK Approved Body will only be required if the UKCA mark is also applied, or is applied instead of the CE mark.
What is the difference between a ‘Notified Body’ and an ‘Approved Body’
A Notified Body is an organisation which is ‘notified’ by a Member State to the European Commission as being competent to fulfil the audit functions defined in one or more of the CE marking directives. An Approved Body performs the same function in the UK, for UK legislation.
Does UKCA apply to goods manufactured and sold before 2020 which are refurbished regularly back to the same specification to which they were originally manufactured and are then re-distributed throughout the UK?
Where maintenance and refurbishment of product takes place that does not affect the performance or has no other effects relating to the health and safety aspects of the product (i.e. a like-for-like replacement of worn components) then the product can continue to be re-sold under its original CE mark without the application of the UKCA mark.
Certifications of welders and welding procedures under the Pressure Equipment Directive are performed by recognised third-party organisations (not Notified Bodies. After Brexit, UK-based RTPOs will lose their EU accreditation. To what extent can an EU based Notified Body continue to accept UKCA based approvals for welding and NDT given the fact that the EU and UKCA approvals are technically identical and only the papers change?
Notified Bodies and Approved Bodies are accredited to make their own decisions about the acceptability of processes and personnel so it does not necessarily follow that RTPO accreditations can no longer be recognised by an EU Notified Body after Brexit.