Many companies have been selling their products with a CE mark in the European Union and in the UK. They are in for a big shock as the UKCA mark comes into force to supersede CE in the UK!
CE vs UKCA
Because of Brexit, there are going to be 2 separate systems. They are going to diverge. And they are going to be non-compatible!
In a nutshell, here is the situation:
- On the one hand, the EU will no longer recognize CE certificates issued by UK-based certifying bodies (e.g. BSI), and will keep evolving their directives & standards.
- On the other hand, the UK will have its own mark (“UKCA”, which stands for “UK Conformity Assessed”) and will soon stop accepting CE certificates. And their national standards body, the British Standards Institution, may develop technical standards that do NOT match those used in the EU.
The CE mark applies to a very wide range of products, from toys to low voltage devices, from PPE to electronics, and from machinery to pressure vessels. This change is going to impact a lot of companies.
Here’s the new UKCA mark to look out for:
(As a side note, the rules seem to be different between Northern Ireland and Great Britain. The CE mark or a new mark (“CE UKNI”) will be required there. In my understanding, if your products are compliant with the UK and EU regulations, you should have no problem there.)
Think about the implications right now
The guidance publication reads:
The UKCA marking can be used from 1 January 2021. However, to allow businesses time to adjust to the new requirements, you will still be able to use the CE marking until 1 January 2022 in most cases.
This does not apply to existing stock, for example if your good was fully manufactured and ready to place on the market before 1 January 2021.
However, the guidance also reads:
If the EU changes its rules and you CE mark your product on the basis of those new rules you will not be able to use the CE marking to sell in Great Britain even before 31 December 2021.
++++++++ UPDATE 25 August 2021 ++++++++
The deadline has been pushed back by 1 year.
Will you have to re-test your products?
If you had to send your products for certification for the CE mark, then, yes, you will have to pay for that process again:
Where mandatory third-party conformity assessment was required for CE marked goods, it will also be required for UKCA marked goods.
This conformity assessment will need to be carried out by a UK-recognised approved body in order to be marked with the UKCA marking. The type of conformity assessment procedures will be the same that were required for the CE marking.
The guidance also mentions the “authorised representative or responsible person”, which will now have to be located in the UK. This might develop into extra requirements, for the UK only.
How will this be enforced?
The market surveillance authorities can still request the technical file for 10 years, just like in the EU.
In addition, Amazon and the other “economic operators” such as warehouses and delivery services will have to enforce these rules:
Until 1 January 2023, for most goods (other than those subject to special rules) you have 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. Products that require the UKCA marking cannot be made available without it (other than where the CE marking is being used before 1 January 2022).
What about medical devices?
The rules will be somewhat different.
First, simply sending products onto the UK market from afar will no longer be so easy. The guidance publication reads:
If you are a manufacturer based outside the UK and wish to place a device on the Great Britain market, you will need to appoint a single UK Responsible Person who will take responsibility for the product in the UK.
Second, a lot of re-testing will be needed. I discussed this with my friend Clive from WWMG, and his understanding is that many sellers of medical devices might have to re-register the devices from scratch if they want to keep selling them in the UK (!).
The rules will keep evolving, but the guidance provided has already been thought through carefully and I don’t expect a 180-degree turn. You need to think about all this if the UK is a significant market for your product. Any thoughts to share? Will you be affected? Let us know by leaving a comment.
P.S. Unsure which certifications are required for your market?
Read this post for a handy tool which will help you find out: What Certifications are Necessary for a Given Product & Country?
We are not lawyers. What we wrote above is based only on our understanding of the regulatory requirements. QualityInspection.org does not present this information as a basis for you to make decisions, and we do not accept any liability if you do so.