UKCA medical devices and IVDs

Qserve is your partner for obtaining a UKCA mark for medical devices and IVDs that comply with UK regulations.
UK Conformity Assessment

UKCA Medical Devices

The UKCA (UK Conformity Assessed) mark indicates that medical devices meet the relevant regulatory requirements for sale within Great Britain (England, Scotland, and Wales). It was introduced following the UK's departure from the European Union to replace the CE mark for products sold in the UK market. 

The UKCA mark ensures that medical devices comply with the UK's specific standards for safety, health, and environmental protection. To obtain this certification, manufacturers must follow a conformity assessment procedure involving testing, documentation, and quality management. The UKCA mark became mandatory for most medical devices on January 1, 2021, with a transition period allowing CE-marked devices until June 30, 2024.



"We can navigate the regulatory requirements for the UK and help you obtain a UKCA mark"

Key steps involved

Process for UKCA medical devices and IVDs approval

To obtain UKCA certification for UKCA medical devices and UKCA in vitro diagnostics, manufacturers must follow these steps:

1. Determine Device Classification: Based on its risk level, identify the medical device's classification (Class I, IIa, IIb, III).

2. Appoint a UK Responsible Person: Non-UK manufacturers must designate a UK Responsible Person to handle regulatory compliance.

3. Conformity Assessment: Conduct the necessary conformity assessment based on the device class.  This includes:

  1. Class I: Self-certification.
  2. Class IIa, IIb, III: Assessment by an Approved Body (similar to an EU Notified Body).

4. Technical Documentation: Prepare comprehensive technical documentation demonstrating the device meets regulatory requirements, including:

  • Device description.
  • Design and manufacturing information.
  • Risk management and clinical evaluation.
  • Performance and safety data.

5. Quality Management System: Implement and maintain a Quality Management System (QMS) compliant with ISO 13485 or equivalent standards.

6. UK Declaration of Conformity: Draft and sign a UK Declaration of Conformity, stating the device complies with UK regulations.

7. Affix UKCA Marking: Once compliance is confirmed, affix the UKCA mark to the product, packaging, and accompanying literature.

8. Register the Device: Before placing it on the market, register the medical device with the Medicines and Healthcare Products Regulatory Agency (MHRA).

By following these steps, manufacturers ensure their medical devices meet UK regulatory standards and can be legally marketed in Great Britain. 


Do you need help understanding the requirements for UKCA medical devices or IVDs? 

Qserve has supported many manufacturers as a UK Responsible Person (UK RP) and provided regulatory, quality, and clinical services to ensure regulatory compliance with UK regulations.

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How can Qserve help?

Our staff is intimately involved with developing the new UK Regulations for medical devices and IVDs. Our experts can share this inside knowledge with our clients to help create submissions in a UK-approved body (Notified Body)- friendly format. We can also guide you through the implementation process from concept to market access in the UK and act as your UK Responsible Person.

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Qserve services for the UK

  • Regulatory strategy
  • Device classification
  • UK Approved Body or Notified Body support
  • UK Responsible Person
  • Technical file preparation
  • Quality Management System (QMS) support
  • UK Clarification of Conformity
  • MHRA device registering
  • Post-market surveillance
  • UK vigilance reporting


CE mark and UKCA mark

Devices can carry CE and UKCA marking if there is EU-MDR or EU-IVDR compliance. Qserve specializes in all the regulatory requirements for Europe and the new UK regulations for medical devices and IVD and knows precisely how to advise manufacturers on the steps they need to take to get regulatory compliance for UKCA. Reach out to one of our experts for a comprehensive gap analysis on existing documentation or how to replace or add the CE marking with the UKCA mark. 

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