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.
The UKCA mark will come into force on 1 Jan 2021, although CE marking will continue to
be recognized in the UK until the end of 31st December 2024. However, from the
beginning of 2025 only products with UKCA marking will be accepted in Great Britain.
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.