UKCA Marking is mandatory for all medical devices sold in the United Kingdom from January 1st, 2023. Most items formerly subject to the CE certification are now subject to the UKCA Mark. Contact us to know in detail about medical device regulations in the UK.

UK Conformity Assessment process has not yet been published officially. However, the UKCA self certification process will likely be similar to new MDR and IVDR regulations covering Clinical evaluation Reports and Performance evaluation reports. All manufacturers planning to sell medical devices in the UK market has to develop an in-house team or identify an external consulting team early for the Conformity Assessment process.

UK Medical Device Regulation 2002 (SI 2002 No 618, UK MDR 2002) is active from January 1st’ 2021. MHRA is under the process of releasing new regulation in line with European Medical Device Regulation. The new regulation is expected to release early 2023.

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 is applied throughout the process of UKCA Marking. Like a technical file built for CE Marking, the UKCA Technical File also contains substantial supporting evidence to demonstrate the medical device’s safety, efficiency, and performance.

• Device risk classification
• Route of UKCA application
• Applicable standards
• Development of Technical documentation
• Biological Evaluation
• Safety Evaluation
• Risk analysis support
• Clinical Evaluation
• Declaration of conformity
• Identify the Certification Body and submit the technical file
• CB onsite visit based on MDQMS and closing of the Non-conformities
• Issue of UKCA certificate

• Guidance on the device classification, Requirements Identification
• Development of Technical documentation
• Biological Evaluation
• Safety Evaluation
• Risk analysis support
• Clinical Evaluation
• Answering UKCA Certification Bodies and update technical documentation

The UKCA mark will go into effect on January 1, 2021, while CE marking will be accepted in the UK until the end of 2022. However, in 2023, only items with the UKCA label will be permitted in the United Kingdom.

As a manufacturer, you must take all measures to prepare for UKCA marking based on your company’s present status and future market access requirements. Importers carry items into the UK from other EU nations or any other foreign country. The importer should ensure the medical device has affixed a UKCA Mark label. As a result, importing a medical or In Vitro diagnostic device from Europe / foreign countries now necessitates using a UKCA mark from the UK Approved Body.

Some devices can be self-declaration and do not need the involvement of an Approved Body. The conditions for self-declaration of conformity for UKCA marking are identical to those for CE marking.

Readers may learn more about UKCA-approved bodies by visiting the website. List of Approved Bodies for Medical Devices

Contact us if you are looking for outsourcing UKCA Marking technical support services for medical and IVD devices.