The UK has left the EU and new rules concerning the transition for most CE products to UKCA products began in January 2021. The transition period for most products ends on December 31, 2021. All products shipped into the UK after that date must have the UKCA mark and a UKCA Declaration of Conformity.
All medical devices placed on the Great Britain market must now be registered with the MHRA.
The UKCA marking in many regards follows the lead of the CE marking used in the EU market. According to the UK government’s Department of Business, Energy & Industrial Strategy, the UKCA mark will apply to Wales, England, and Scotland. The UKCA marking cannot be used for products placed on the Northern Ireland market. These products will require a CE marking or a UKNI marking.
What is the UKCA marking?
The UKCA (UK Conformity Assessed) marking is the new UK product marking used for goods that hope to be placed on the market in Great Britain (England, Wales, and Scotland). In most cases, these goods previously required CE marking.
Do I need a UKCA marking?
The UKCA marking came into effect on January 1st, 2021, but an adjustment period will be in place until January 1st, 2022; where you will still be able to use a CE marking in most cases. F2 Labs recommends that you schedule testing as soon as possible to meet the deadline for this transition. For exceptions keep reading.
How exactly is UKCA different than CE?
The technical requirements and conformity assessment process and standards that demonstrate conformity for both the UKCA and CE markings are largely the same.
What are the exceptions?
If I get UKCA testing, do I need CE testing?
Yes, if you want to sell your product in the EU. The UKCA marking is not recognized in the EU market. At the end of the 2021 transition period, the CE mark will not be recognized in the UK market.
Product Labeling with UKCA
In most cases, you must apply the UKCA marking on the product itself or the packaging. Some general rules when using the UKCA marking:
- UKCA markings must be placed on the product by the manufacturer or an authorized representative
- Placing the UKCA marking makes you responsible for the product’s conformity with the requirements of the relevant legislation
- Only use UKCA marking to show conformity with relevant UK legislation
- Do not use UKCA marking products that do not have a specific requirement to do so
In relation to the use of the UKCA image, make sure that:
- Is in proportion to the one shown below
- Is at least 5mm in height (unless otherwise specified in legislation)
- Is easily visible & legible
- Is permanently attached* (unless otherwise specified in legislation) *starting January 2023
UKCA Technical Documentation
Technical documentation that demonstrates your product’s conformity with regulatory requirements must be kept for up to 10 years after the product is placed on the market. Product documentation can be requested at any time by market surveillance or enforcement authorities, for the safety of the public. The information requested will vary depending on specific legislation pertaining to your product, generally include:
- how the product is designed and manufactured
- how the product has been shown to conform to relevant requirements
- the address of the manufacturer and any storage facilities
UK Declaration of Conformity
Most products must be supplied to the end-user with a declaration of conformity. The declaration of conformity declares key information about the product, including:
- your name and full business address
- the product’s serial number, model, or type identification
- a statement, stating you take full responsibility for the product’s compliance
- the details of the approved body which carried out the conformity assessment procedure (if applicable)
- the relevant legislation with which the product complies
- your name and signature
- the date the declaration was issued
- supplementary information (if applicable)
Similarly to the technical documentation, the declaration of conformity should be available to market surveillance authorities on request.
Products covered by the UKCA marking
- Toy safety
- Recreational craft and personal watercraft
- Simple pressure vessels
- Electromagnetic compatibility
- Non-automatic weighing instruments
- Measuring instruments
- Radio equipment
- Pressure equipment
- Personal protective equipment
- Gas appliances
- Equipment for use outdoors
- Low voltage electrical equipment
- Restriction of hazardous substances
- medical devices*
- rail interoperability*
- construction products*
- civil explosives*
*covered by UKCA marking, but have special rules.