What is UKCA Certification?

The UKCA Mark ensures that medical devices meet the UK’s stringent safety and performance criteria as defined under the UK Medical Devices Regulations 2002 (as amended). It serves as a declaration by the manufacturer that the product is safe, effective, and compliant with regulatory standards.

Benefits include:

• Legal market access to England, Wales, and Scotland
   
• Proof of compliance with MHRA safety and quality standards
   
• Stronger market credibility with buyers, regulators, and healthcare providers
   
• Protection from regulatory penalties, import refusals, or recalls
   

Note: While UKCA replaces CE marking in GB, it does not apply to Northern Ireland, which continues to follow the EU CE framework due to the Northern Ireland Protocol.

UKCA Certification Consultants provide expert regulatory guidance to help manufacturers navigate the evolving UK compliance landscape. At RAPS, we support you through every step of the certification process:

• Interpret UK MDR 2002 regulations and determine applicable conformity routes
   
• Perform gap analysis and documentation reviews for compliance
   
• Guide you through QMS requirements aligned with ISO 13485
   
• Develop technical documentation, including risk assessments and clinical evaluations
   
• Support audit preparation and interface with UK Approved Bodies
   
• Ensure timely registration with MHRA and SRN requirements
   
• Assist with labeling updates to include UKCA marking and Representative details
   
• Monitor regulatory changes and provide ongoing compliance support
   

Our consultants stay up-to-date with every update from MHRA, ensuring your product lifecycle aligns with the latest compliance expectations.

To successfully obtain UKCA Certification for medical devices and IVDs sold in Great Britain, manufacturers must compile a comprehensive technical file that clearly demonstrates their product’s compliance with relevant UK regulations. However, for many Quality Assurance (QA) and Regulatory Affairs (RA) teams, preparing and segmenting technical files correctly can be a challenging and time-consuming task.

A UKCA technical file (or technical documentation) serves as formal proof that your medical device meets UK Medical Devices Regulations (UK MDR 2002, as amended). This file must include evidence related to the design, manufacturing process, intended use, performance, and safety of the device.

Correct structuring and categorization of the technical file are vital for a smooth review process by UK Conformity Assessment Bodies (UK CABs). Grouping multiple devices under a single file is only acceptable if those devices share:

• The same intended purpose and use
   
• Similar risk classification
   
• Identical or closely related materials and construction
   
• No major design differences
   

Improperly grouped products can lead to delays, nonconformities, or rejection of your UKCA application.

Your technical file should include detailed and updated information on the following:

• Device Description
   
  • Intended use
     
  • Indications for use
     
  • GMDN/EMDN coding
     
  • Product variants and configurations
     
• Design and Manufacturing Information
   
  • Drawings, specifications, and materials
     
  • Manufacturing process overview
     
  • Quality control procedures
     
• Risk Management
   
  • Risk analysis (ISO 14971 compliance)
     
  • Hazard identification and control measures
     
  • Benefit-risk justification
     
• Performance Evaluation
   
  • Clinical and/or pre-clinical data
     
  • Biocompatibility, electrical safety, and EMC tests (where applicable)
     
  • Software validation and cybersecurity (if applicable)
     
• Labelling and Instructions for Use (IFU)
   
  • Packaging labels
     
  • User manuals
     
  • Regulatory symbols and warnings
     
• Declaration of Conformity
   
  • Statement affirming compliance with applicable UK standards
     
  • Signature of the authorized person
     

To avoid complications during UKCA certification, manufacturers should maintain separate technical files when devices differ in:

• Intended use or indication
   
• Risk classification
   
• Material composition or biocompatibility
   
• Design, software, or firmware components
   
• Conformity with different directives or regulations
   
• State-of-the-art considerations
   
• Use of distinct accessories or components
   

After Brexit, all UK-based Notified Bodies were re-designated as UK Conformity Assessment Bodies (UK CABs). From January 1, 2021, CE certificates issued by EU Notified Bodies are no longer valid for placing products on the GB market. Manufacturers must now work with UK-approved bodies for UKCA marking.

A common question among manufacturers is whether UKCABs accept existing CE certifications as part of the UKCA process. The answer is yes, but only under specific conditions:

• The EU Notified Body must agree to share documentation and cooperate with the UK CAB upon the manufacturer’s request.
   
• If this collaboration isn’t possible, the UK CAB may require a full re-assessment, including on-site audits and technical documentation review—resulting in added time and cost.
   

At RAPS, we help you navigate this process and liaise with UK CABs and EU Notified Bodies to streamline your certification path.

Achieving UKCA certification requires a strategic and well-documented approach. Here's a breakdown of the UKCA conformity assessment process:

1. Identify applicable UK regulations and standards
    
   • Understand device classification under UK MDR 2002
      
   • Review relevant guidance from MHRA
      

1. Conduct a gap analysis
    
   • Compare existing documentation with UKCA requirements
      
   • Identify missing elements or outdated procedures
      

1. Perform necessary testing and evaluations
    
   • Safety, biocompatibility, and clinical data (as required)
      
   • Software and usability testing if applicable
      

1. Compile the technical documentation
    
   • Follow the format and depth expected by UK CABs
      
   • Maintain traceability from risk analysis to test reports
      

1. Engage a UK Approved Body (if required)
    
   • Submit your documentation for review
      
   • Participate in the on-site quality system audit
      

1. Issue the Declaration of Conformity
    
   • Final step once your conformity has been validated
      

1. Affix the UKCA Mark
    
   • Ensure labeling complies with UK guidelines
      

At RAPS, we offer end-to-end support for preparing and maintaining your UKCA technical files. Our team helps you:

• Develop structured, audit-ready documentation
   
• Separate or combine files based on device characteristics
   
• Prepare for audits and regulatory reviews
   
• Manage communication between EU Notified Bodies and UK CABs
   
• Keep your documentation current with UK regulatory changes
   

Don’t let technical file complexity slow down your path to compliance. Whether you're transitioning from CE to UKCA, introducing a new device, or facing a CAB audit, RAPS is your trusted regulatory partner for strategic, reliable support.

Contact us today to schedule a consultation with our UKCA documentation experts.
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