UKCA Marking
If you’re looking to launch a new IVD 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 IVDs within Great Britain.
FAQs on UKCA Marking
The UKCA Mark will soon replace the CE Mark for IVDs sold in Great Britain.
Here are some of the questions we get asked most often.
Following Brexit, the UK Conformity Assessment (UKCA) Mark will soon replace the CE Mark for products sold in Great Britain.
Governed by the Medical Devices Regulations 2002 (UK MDR 2002), IVDs may need to obtain a conformity assessment certificate from a UK Approved Body to demonstrate compliance.
Our Services
Through our skills and experience in the IVD industries, we can offer a range of services to help non-UK-based manufacturers achieve UKCA Marking.