From 1 January 2021, any products being placed on the UK market will now need to bear the UKCA marking to demonstrate product conformity with relevant UK legislation. The new marking has replaced the former CE mark used for products sold within the European Economic Area.
From machinery to medical devices, the mark is an administrative indication of conformity with health, safety, and environmental protection standard for most manufactured products placed on the EU market.
CE Marking after Brexit
The new UKCA regime is being phased in, with the CE mark remaining temporarily valid to ease the changeover. However, businesses are being encouraged to use the new UKCA mark as soon as possible after 1 January 2021.
Many aspects of the UKCA will initially remain the same as the CE marking after Brexit such as the products covered, technical requirements and conformity assessment procedures.
To allow businesses time to adjust, the government has agreed CE marked products that meet EU requirements can continue to be placed on the UK market until 1 January 2022 in most cases. If you have already placed your product on the UK or EU market – in circulation - before 1 January 2021, you do not need to do anything.
However, some products will have to cohere to the UKCA marking immediately, this will apply to products that meet all the following:
- The product is for the UK market
- It is covered by laws requiring UKCA marking
- It requires mandatory third-party conformity assessment
- Conformity assessment has been carried out by a UK conformity assessment body
This does not apply to existing stock, for example if your product was fully manufactured, CE marked and ready to place on the market before 1 January 2021. If you use the UKCA mark you will need to draw up a UK declaration of conformity. This should be available to market surveillance authorities on request.
Conformity assessment bodies
From 1 January 2021, all UK-based EU ‘notified bodies’ will automatically become UK approved, they can be found listed on the EU NANDO database and UKAS website. If you self-certify or use an EU notified body, you will still be able to use the CE marking until 1 January 2022 even for products that are manufactured after 1 January 2021.
Manufacturers may require separate UK and EU certificates from 1 January 2021.
Selling products in the EU
The UKCA marking is not recognised on the EU market, including Northern Ireland. Products for sale in the EU will need a CE marking. You can place the UKCA and CE marking on the same product if it is destined for both the UK and EU markets (so long as the product meets the relevant regulatory requirements for both markets).
Technical requirements and conformity assessment
The technical requirements and conformity assessment processes will largely remain the same. Manufacturers using EU-based notified bodies will need to obtain UK-based bodies to complete conformity assessments before using the UKCA mark.
Similarly, businesses using UK-based notified bodies to assess conformity of products with EU regulations will need to contract EU-based notified bodies to verify their products.
Classified importers will be responsible for ensuring the correct conformity assessment procedures have been carried out and the appropriate conformity markings have been applied. The government has set-up a new UK Market Conformity Assessment Bodies (UKMCAB) database that lists all bodies that can provide conformity assessment for products placed on the UK market.
Although the rules described above will apply in most cases, it is important for healthcare and life science businesses to be aware that the CE marking will continue to be used for medical devices until 30 June 2023. From 1 July 2023, UKCA marking will be required for the supply of medical devices to England, Scotland and Wales, with Northern Ireland retaining CE marking.
But 1 January 2021 did see several changes to how medical devices are placed on the market in the UK. A new method to market and product marking is available for manufacturers wishing to place a device on the UK market. All medical devices, including In Vitro Diagnostic Medical Devices (IVDs), placed on the UK market need to be registered with the MHRA.
Applying software for CE and UKCA marking
Keeping on top of your product conformity requirements will now become more complex and time-consuming than ever, with many businesses juggling a mixture of UKCA and CE marking obligations.
Quality management software can be applied in multiple ways to simplify, streamline and support your product conformity processes and ease your organisation’s compliance burden.
Is your business facing a bewildering patchwork of CE and UKCA requirements for the future?
Q-Pulse Law is designed to offer users a live and real-time library of their legal and compliance demands. Market and territory updates from Ideagen’s expert team are fed into a bespoke legal profile for your business that lays out a step-by-step and country-by-country breakdown of your specific legislative requirements – so you can take guided and targeted action to maintain compliance without worrying about mapping your shifting compliance demands yourself.
Looking to embed deeper control and visibility of your product portfolio?
Q-Pulse QMS gives you complete digital cloud-based management of your quality and compliance:
- Store, secure, categorise and control all product conformity documentation in a single repository, from CE certificates and UKCA declarations of conformity to internal certification processes and product development information.
- Build digital workflows to funnel actions to the right personnel at the right time for a controlled product conformity approach.
- Audit your products and manufacturing processes to uncover risks and opportunities and drive UKCA and CE compliance from design to post-market surveillance.
Need even more targeted product management control, such as PPAP, NPI and FAIR procedures?
Apply our dedicated product management software system, Q-Pulse PM, for even sharper control.
To ensure your business is complying to the new UKCA marking regime, find out more about our software solutions.