Confirm compliance with UK Conformity Assessed (UKCA) mark guidelines with assessment and certification services from SGS.
As the UK has left the EU, several changes and updated legislation impact how medical devices are placed on the market. The Medicinal and Healthcare product Regulating Agency (MHRA) oversees which products are available in England, Scotland, Wales and Northern Ireland.
Products for England, Scotland and Wales must now follow UKCA mark guidelines. As an Approved Body, SGS can certify your technical documentation to confirm that it meets the UKCA mark guidelines and MHRA requirements.
Why choose SGS for your UKCA certification requirements?
We can help you to:
Understand the UKCA mark requirements
Confirm that your products meet UKCA mark and MHRA requirements
Acquire up-to-date UKCA certification to ensure market access
We are the world’s leading provider of testing, inspection and certification services. We are recognized as the global benchmark for quality and integrity. Our 96,000 employees operate a network of 2,700 offices and laboratories, working together to enable a better, safer and more interconnected world.
The UKCA mark requirements imposed by the UK government currently mirror EU MDR compliance, are complex and apply to multiple device types, including Class IIa, Class IIb (implantable and non-implantable) and Class III devices.
According to the MHRA: “[A]ll medical devices, including in vitro diagnostic medical devices (IVDs), custom-made devices and systems or procedure packs, need to be registered with the MHRA before they are placed on the Great Britain market”. A valid CE mark will continue to be recognized in Great Britain, as will certificates issued by Notified Bodies recognized by the EU until June 30, 2024.
Providing the unrivalled expertise you need for a smooth certification process, we are:
- A Notified Body in Belgium (1639)
- A Notified Body in Finland (0598) for clients needing certification specifically for Software as a Medical Device (SaMD)
- An Approved Body for the UKCA mark (AB0120)
- An Approved Auditing Organization (AO) for MDSAP
- Integrated and/or combined audit solutions to help you save time and money
- Assessment and certification services for specific medical device requirements
- A dedicated account management team to ensure that your certification project gets the relevant support
- Global resources and a local presence – our people speak the language, understand the local market culture and operate globally
For more information regarding MHRA requirements and the UKCA mark, please visit the medical device page on the UK government website.