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 Marking Medical Devices 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 Devices Regulation. The new regulation is expected to release early 2023.
The UKCA (UK Conformity Assessed) Marking holds immense importance for product compliance in the UK market post-Brexit. As the UK’s new product marking system, it has replaced the CE Marking for most products sold in Great Britain. This change was necessitated by the UK’s withdrawal from the European Union, enabling the country to establish its own regulations and conformity assessment procedures. The UKCA Marking serves as a clear indicator that a product meets the required safety and quality standards set by UK authorities, ensuring its suitability for sale and use within the UK market.
For businesses operating in the UK, obtaining the UKCA Marking is not just a matter of legal compliance; it is a vital step towards gaining access to the UK market. Without this mark, products may face restrictions or even be deemed non-compliant, hindering their entry into the marketplace. By undergoing the necessary conformity assessment procedures and affixing the UKCA Mark, companies signal their commitment to adhering to UK regulations, thus earning the trust of consumers and regulators alike.
Consumer trust is an essential aspect of any successful business, and the UKCA Marking plays a significant role in bolstering this trust. When consumers see the UKCA Mark on a product, they can be confident that it has undergone rigorous testing and meets the required safety standards. This assurance not only benefits consumers but also enhances the reputation of the manufacturer or importer, as it showcases their dedication to producing safe and compliant products.
As of my last update in September 2021, the products that require UKCA (UK Conformity Assessed) Marking for compliance in the UK market can vary based on the specific regulations and standards. Generally, the UKCA Marking is required for most goods sold in Great Britain that previously required the CE Marking when the UK was part of the European Union. Here are some product categories that typically require UKCA Marking:
It’s important to note that the UK government may update the list of products requiring UKCA Marking, and specific regulations might differ for Northern Ireland due to the Northern Ireland Protocol. For the most up-to-date and comprehensive information on which products require UKCA Marking, manufacturers, importers, and distributors should refer to the UK government’s official guidance or consult with a conformity assessment body or a legal expert familiar with UK product regulations.
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
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.
