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UKCA Marking

Clinical and Post-Market Services

If you’re looking to launch a new medical device in the UK, we can help. By partnering with us, we can guarantee your products meet the necessary UKCA requirements to ensure complete regulatory compliance.

Launch products in the UK market with confidence

Work with a partner you can trust 

At Apotech, we are well-versed in the UK’s regulatory requirements. Our seasoned consultants can provide expert support throughout the compliance process, helping you minimise any potential regulatory risks to successfully launch new medical products within Great Britain.

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FAQs on UKCA Marking

The UKCA Mark has replaced the CE Mark for medical devices sold in Great Britain

Here are some of the questions we get asked most often.

Following Brexit, the UK Conformity Assessment (UKCA) Mark has replaced the CE Mark for products sold in Great Britain.

Now governed by the Medical Devices Regulations 2002 (UK MDR 2002), medical devices must obtain a conformity assessment certificate from a UK Approved Body to demonstrate compliance. 

Our Services

Through our skills and experience in the MedTech industries, we can offer a range of services to help non-UK-based manufacturers achieve UKCA Marking.

  • Regulatory road-mapping
  • Technical documentation compilation
  • Clinical Evaluation Reports (CER)
  • Risk management
  • Gap analysis
  • UKRP services
  • Approved Body selection and liaison

Ready to get started?