UK Conformity Assessed (UKCA)

-Is this the lifesaver for UK market?

When United Kingdom (UK) decided to leave European Union, manufacturers had no clue on which regulations to follow. To avoid the situation, UK put forth a new regulation known as UKCA marking to fill the gaps left by CE marking. This change in regulation will have a massive impact on supply chains that interact with UK. Due to this, organizations must be aware of the details to ensure they correctly prepare for it, mitigating any chances of any potential issues.

The UKCA (United Kingdom Conformity Assessment) marking is a regulatory norm established for goods to market in Great Britain (GB). The areas under GB include England, Wales and Scotland (Except Northern Ireland). It will be used as a replacement for CE marking on goods sold in the GB market. It captures majority of products which were previously required CE marking, known as ‘new approach’ goods. The UKCA marking came into effect on 1 January 2021. To allow the manufacturers or businesses to adjust to the new requirements, CE marking will be valid until 1 January 2023. Products can carry both CE and UKCA marking if they fulfill the regulations of both the legislation. 

Selling products in Great Britain (GB)

The UKCA marking applies to the products which are previously subjected to CE marking. Compliance to technical documentation requirements, conformity assessment processes, and standards used to demonstrate conformity largely remains same as CE marking. 

The circumstance in which self declaration applies to CE marking remains same for UKCA also. The CE marking is only valid GB areas where both the rules remain same. In case of any change in EU rules and if manufacturer gets the approval based on new rules, then the CE marked devices cannot marketed in GB even before 1 January 2023. 

Selling products in Northern Ireland (NI)

Under the NI protocol, the areas still abide by European Union (EU) rules for some products. As a result, NI continues to recognize the CE Mark but does not recognize the UKCA mark.

There are two options for the importers or for the manufacturers to place the products on the NI market, either through (a) conformity assessment by a Notified Body (NB) from one of the EU member states or (b) Conformity assessment by a UK based NB. If the second option is followed, then the product must be marked with UKNI marking in addition to CE mark which denotes that the conformity assessment activities were undertaken within the UK. Products bearing the combined CE UKNI Marks shall not be accepted on the EU market.

Selling products in European Union (EU)

The UKCA marking is not recognized on the EU market. Products need a CE marking for sale in the EU.

When to use the UKCA marking

UKCA marking is needed if the product 

How to use the UKCA marking

General rules –

a) The UKCA must be clear and legible when affixed on to the product. If this is not possible, it should be attached to the packaging (if any) or any relevant document. 

b) UKCA marking must be placed by the manufacturer or Authorised representative (where permitted in the relevant legislation)

c) When UKCA marking is affixed, it is the full responsibility of the concerned party to comply to required legislation

d) UKCA marking used only to demonstrate conformity with the relevant UK legislation

e) The UKCA marking cannot be placed on products unless there is specific requirement to do so in legislation

f) A product may have additional marking, as long as they –

-Fulfil a different function from that of the UKCA marking

-Are not likely to cause confusion with the UKCA marking

-Do not reduce the legibility and visibility of the UKCA marking

Rules for using UKCA image

The concerned party must keep the following points in mind when affixing UKCA image. They are

a) The UKCA marking should be at least 5 mm in height, unless different dimension mentioned in the relevant legislation

b) The marking should be visible and legible

c) The marking can have varied forms, as long as it follows the above mentioned norms

Technical Documentation

The technical documentation must be in place for the product to demonstrate the conformity to the regulatory norms. Either the manufacturer or the authorized representative can maintain the required documents. This must be kept for up to 10 years after the product is place on the market. This information can be requested by the concerned authority at any time to check the compliance of product to legislation.

The information varies for the specific product based on specific legislation. The concerned party must keep the records of:

a) How the product is designed and manufactured

b) How the product has been shown to conform to the relevant requirements

c) The addresses of the manufacturer and any storage facilities

UK Declaration of Conformity 

It is a document which must be drawn up for most products lawfully bearing a UKCA marking. It is recommended that manufacturers have a separate UK Declaration of Conformity to their EU Declaration of Conformity.

In the document you as the manufacturer, or your authorised representative (where allowed for in the relevant legislation), should:

a) Declare that the product is in conformity with the relevant statutory requirements applicable to the specific product

b) Make sure the document has the name and address of the manufacturer (or your authorised representative) together  with information about the product and the conformity assessment body (where relevant)

The UK Declaration of Conformity should be available to market surveillance authorities upon request. The information required on the Declaration of Conformity is largely the same as what was required on an EU Declaration of Conformity.

Start your transition from CE to UKCA marking with us at KN CONSULTING AND SERVICES.

KN CONSULTING AND SERVICES is a well-oiled marvel in the field of Medical devices regulatory consulting. We can provide you with flexible and detailed planning and consulting services suiting to your needs.