The new product marking requirement for certain products to be placed in Great Britain and Northern Ireland’s market is the UK Conformity Assessment (UKCA) mark. Here is what you need to know to comply with the UKCA legislation and put your goods on the market in Northern Ireland.
What marking applies in Northern Ireland?
The CE mark is still legal for self-assessed goods and goods that are conformity assessed by an EU Notified Body. 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:
- Gas Appliances
- Low Voltage Electrical Equipment
- Measuring Instruments
- Radio Equipment
Medical devices are covered by UKCA marking but also have specific requirements.
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
Shiro Business Solutions explains the UKCA mark in our blog entitled “What is the UK Conformity Assessed Mark (UKCA)?“
In simple terms, it is the product mark now being used for goods 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.
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 it 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, 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.
Placing goods on the market in Northern Ireland
The Northern Ireland Protocol is now international law, as the UK and EU signed it as part of the Brexit withdrawal agreement. This protocol means that Northern Ireland will continue to follow EU rules on product standards, and any inspections and document checks will be conducted between Northern Ireland and Great Britain instead of at the Irish border.
This means that medical device manufacturers who want to place items on the market in NI still need to meet the relevant EU rules, including CE marking, if they undertake self-assessment.
If your products qualify for the Northern Ireland market and are in free circulation there, they can also be placed on the market in Great Britain – even if EU and GB rules on these products differ. This arrangement covers products with just a CE mark and those with CE plus UKNI marking.
Importer responsibilities in Northern Ireland
There are slight differences between an Importer’s responsibilities in Northern Ireland, depending on whether they place goods on the Northern Ireland market from Great Britain, non-EU countries, or outside the UK.
If you are an importer bringing goods into NI from GB or another non-EU country and placing them on the NI market, then you need to ensure the goods are labelled with your details AND that the correct conformity assessment has been carried out.
If you are a business based in NI and are placing goods from outside the UK onto the GB market, these goods must be labelled with your details.
Shiro Business Solutions works closely with MedEnvoy, who have 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.