UKCA Mark
UKCA Mark for Medical Devices
We remain fully committed to participating again and are looking forward to doing so once the framework is clearly defined.
Following a period of regulatory transition, the UK Government and the Medicines and Healthcare products Regulatory Agency (MHRA) are now advancing reforms to modernize the system, improve efficiency, and increasing alignment with internationally recognized standards and regulatory practices, including initiatives such as the Medical Device Single Audit Program (MDSAP).
As the future UK regulatory framework continues to evolve, DEKRA has decided not to offer UKCA certification services for medical devices at this time, helping manufacturers avoid unnecessary financial and operational investment in certification pathways that may change. We remain fully committed to participating again once the framework is clearly defined.
This whitepaper outlines the current UK regulatory landscape, highlights upcoming developments such as international recognition and MDSAP, and explains DEKRA's position.
Understanding the UKCA Mark
UKCA (UK Conformity Assessed) marking was introduced following the United Kingdom’s departure from the European Union as the new product conformity marking for goods placed on the market in Great Britain.
In the context of medical devices and in vitro diagnostic devices (IVDs), the UKCA mark indicates that a product complies with the applicable UK regulatory requirements, as set out under the UK Medical Devices Regulations 2002 (as amended), which are largely based on the former EU framework.
The UKCA marking applies to products placed on the market in Great Britain (England, Scotland, and Wales) and replaces the CE marking for most regulated products in the long term. However, there is currently a transitional period in place during which CE-marked devices may still be accepted in Great Britain, subject to specific conditions and timelines defined by the Medicines and Healthcare products Regulatory Agency (MHRA).
As regulatory requirements continue to evolve, it is important to note that timelines and compliance obligations may change. Customers are therefore encouraged to stay up to date with the latest MHRA announcements to ensure continued compliance with current UK regulatory expectations.
How DEKRA Supports Manufacturers
Supported by a global network of offices and state-of-the-art laboratories, DEKRA provides certification services that facilitate worldwide market access for medical devices, including:
- Europe (CE Certification),
- Australia, Brazil, Canada, Japan, and the U.S. (under MDSAP certification),
- Singapore, Taiwan, and South Africa.