The UK Conformity Assessment (UKCA) mark is the new UK product marking required for certain products to be placed in Great Britain’s market. This article will summarise what you need to know to comply with the legislation, enabling you to put your goods on the market.
What marking applies where?
There are two areas you need to think about when it comes to UKCA marking:
- Great Britain (UK): The UKCA mark replaces the previous reverse epsilon marking. From 1 Jan 2023, the UKCA mark will be mandatory for goods placed on the market in Great Britain.
- Northern Ireland (UK): For self-assessed goods and goods which are conformity assessed by an EU Notified Body, the CE mark is still legal. If the goods are conformity assessed by a UK Notified Body, the CE plus UKNI mark is used.
What is covered by UKCA marking?
There are a variety of manufactured goods covered by the UKCA marking, including:
- Measuring Instruments
- Radio Equipment
- Gas Appliances
- Low Voltage Electrical Equipment
Medical devices are covered by UKCA marking but have some particular requirements that are specific to them.
Timeline to implement UKCA marking
The UKCA mark is replacing the CE mark. The critical dates related to this are:
- Until 31 Dec 2022 – CE marking can still be used while we prepare to transition to the UKCA mark
- After 31 Dec 2022 – UKCA marking must be used
- Until 30 June 2023 – CE marking can be used on medical devices while we prepare to transition to the UKCA mark
- Until 31 Dec 2023 – UKCA marking can be applied via an accompanying document or sticky label (for most goods)
- After 31 Dec 2023 – The UKCA mark must be applied directly to the product (this is different for Medical Devices).
The UKCA mark
We offer a detailed explanation of the UKCA mark in our blog entitled “What is the UK Conformity Assessed Mark (UKCA)?” but in simple terms, it is the product mark now being used for goods being placed on the market in Great Britain – which used to be covered by the CE mark.
Routes to UKCA mark assessment
To place the UKCA mark on your medical device, you must prove that it complies with the UK MDR 2002 by completing a conformity assessment. Depending on your product, this could be either a self-declaration or a third-party conformity assessment. You must contact an approved body immediately if your product needs a third-party conformity assessment.
It is also vital that you keep documentation relating to the conformity of your products with regulatory requirements. For example, if your product bears the UKCA mark, you must have a UK Declaration of Conformity drawn up for it to be legal.
How to comply with market surveillance
Despite the changes to the UKCA mark, there haven’t been any changes to market surveillance and market surveillance policy. However, a new UK-specific market surveillance database has been created to help the UK’s Market Surveillance Authorities (MSAs), HMRC and the border force monitor and enforce the law.
Economic operators
An economic operator’s role in the international supply chain meets the standards and criteria required to be an Authorised Economic Operator.
There are four main types of economic operators, and these are:
- Manufacturer – The person who manufactures a product or has a product manufactured and markets it under its name or trademark.
- Importer – The person who is the first to place goods from an external market onto the market in which they are established and operate.
- Distributor – The person, other than the manufacturer, importer or end user, who makes the goods available on the market.
- Authorised Representative – The person or business appointed and mandated by the manufacturer to undertake specific tasks on their behalf.
Each of these operators has specific roles when it comes to UKCA marking, and these roles are:
- Manufacturers – ensure products comply with the relevant rules, ensure the applicable conformity assessment procedure has been carried out, and appropriate marking has been fixed to the goods, ensure their details are indicated on the goods or packaging and draw up the technical documentation and a UK Declaration of Conformity (DoC).
- Importers – ensure the manufacturer has completed the relevant conformity assessment procedure, drawn up technical documentation and affixed the appropriate mark. The importer’s details should also be indicated on the goods, packaging, or accompanying documentation. They should also retain a copy of the UK DoC for ten years from the date the product is placed on the market.
- Authorised Representative – If you want to market your product in GB, your authorised representative must be based in the UK or NI. Your authorised representative can draw up the UK DoC, affix the UKCA mark, keep technical documentation, and cooperate with the market surveillance authorities.
- Distributors – Your distributor and fulfilment service provider should ensure your product meets legislation requirements before it is available on the market. They may also provide services to other economic operators.
What is placing goods on the market vs putting them into service in Great Britain?
Sometimes regulations talk about “putting goods into service” rather than “placing goods on the market.” But what’s the difference?
According to the BEIS (Department for Business, Energy and Industrial Strategy), an individual product is considered as being “placed on the market” when it is first made available for distribution, consumption or use on the GB market.”
Putting goods into service is different as this “takes place the first time a product is used in GB by the end user for its intended purpose.”
Regarding the UKCA marking timeline, the UKCA mark would be applied; then the product would be “placed on the market”, and then it would be “put into service” once it had reached the end user.
Shiro Business Solutions works closely with MedEnvoy, which has offices in the UK, US, Switzerland and the Netherlands – ideally placing us to offer you straightforward economic operator services. Please get in touch to find out more.
Julian Relf
I have a wealth of experience and success gained in UK and European sales, marketing and management roles within the Medical Devices and Medical fields with both Start-up and Blue-chip companies.