UKCA Marking Regulation

UKCA (UK Conformity Assessed) is the product conformity mark for the United Kingdom (UK), which will be mandatory for most of the goods placed on the market in Great Britain (England, Wales, and Scotland) beginning January 1, 2023. UKCA marks will replace CE marks on goods previously required to bear the CE mark.

Our UKCA Services can help you comply with UKCA regulatory needs and support your market access needs. We can provide first-hand insight into the requirements of the UKCA thanks to our global compliance experts. With their industry-specific knowledge and expertise, you can be confident that our engineers will understand the challenges you face in manufacturing UKCA compliant products.

After a product is placed on the market, records should be maintained by the company or its authorized representative for 10 years. It is to demonstrate the product meets the regulatory requirement. In order to check the conformity of the product, the authorities can request this information at any time.

ComplianceXL offers the full spectrum of UKCA regulatory services, including consultancy, data collection, creating EU DoC for CE marking and UK DoC for UKCA applicable products.

In cases where organizations already have CE marking, we work together to minimize the additional activities required for UKCA marking. We combine activities to maintain certificates with your current CE marking schedule when possible and perform an abridged UKCA assessment using existing CE reports. Existing customers are encouraged to apply for UKCA certification, and we support documentation as well.

It is mandatory to register all medical devices placed on the market with the government’s regulatory agency, the Medicines and Healthcare Products Regulatory Agency (MHRA). The MHRA will be responsible for vigilance, sampling, and incident management for all devices sold in the UK. UK manufacturers can register their products directly with MHRA but manufacturers outside the UK will need to appoint a Responsible Person.

ComplianceXL is committed to supporting its customers with the implementation of UKCA marking. We have developed a robust UKCA conformity assessment process to be delivered by our associates in the UK.

UKCA-marking for medical devices requires a third-party assessment by a UK-accredited organization. The process is similar to that used in the EU for CE marking, in which the conformity assessment of devices is done by a designated Notified Body.

Declaration of Conformity

A UK Declaration of Conformity is required for most products lawfully bearing the UKCA marking. In general, the information required for the Declaration of Conformity will be the same as that required for an EU Declaration of Conformity.

A business, or an authorized representative (where allowed by applicable legislation), should:

  • Confirm that a product is compliant with the relevant statutory regulations for the specific product.
  • Make sure to include the name and address of the manufacturer (or an authorized representative of the manufacturer) as well as information about the product and the conformity assessment body (when applicable).

Get in touch with ComplianceXL today to learn how we can help you market your products or services in Great Britain.

Click here to get further information on what you need to know about UKCA marking.