United Kingdom Market
UKCA Marking
Medical Device
IVD
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What is UKCA Marking?
The UKCA (UK Conformity Assessed) marking is a new UK product marking that is required for certain products, including medical devices and in vitro diagnostic devices, placed on the market in the UK.
The UKCA marking replaces the CE marking in the UK following Brexit. The UKCA marking signifies that the product conforms to relevant UK regulations and standards.
The service of obtaining the UKCA marking includes product testing, assessment, and certification by a UK Approved Body (UKAB) such as the MHRA (Medicines and Healthcare products Regulatory Agency) or UKRP (UK Approved Body for Product Certification).
Why is UKCA Marking important?
This service is important to ensure compliance with UK regulations and to maintain access to the UK market for medical devices and IVDs.
Process Flow for UKCA Marking
Understand UKCA Marking Requirements: Familiarize yourself with the specific requirements for UKCA marking applicable to your products.
Assess Product Compliance: Evaluate the compliance of your products with the applicable UK regulations and standards.
Update Documentation: Review and update your product documentation to reflect the UKCA marking requirements. This may include technical files, product specifications, test reports, and conformity assessment documentation.
Engage with a UK Approved Body: Depending on your product category and regulatory requirements, engage with a UK approved body for conformity assessment. This may involve testing, inspection, or certification processes to ensure compliance with UK regulations.
Apply UKCA Marking: Once your products have successfully met the UKCA marking requirements and obtained the required certifications, affix the UKCA mark on your products, packaging, or accompanying documentation.
Update Marketing Materials: Revise your marketing materials, including product labels, packaging, and promotional content, to include the UKCA mark and comply with the UK regulations.
Maintain Compliance: Continuously monitor and update your products to maintain compliance with the UKCA marking requirements. Adapt your processes and documentation accordingly to ensure ongoing compliance.
Keep Records and Documentation: Maintain organized records and documentation related to the UKCA marking process. Ensure that these records are readily available for inspection by regulatory authorities, if required.
Stay Updated on Brexit Impact: Stay informed about the impact of Brexit on regulations and market access.
How can we help in UKCA Marking?
The CliniExperts professionals will -
Ensure that your products meet the necessary technical requirements, safety standards, and performance criteria specified for the UK market.
Monitor any changes in the UK regulatory landscape and align your strategies and compliance efforts accordingly.
Ensure that the documentation accurately demonstrates compliance with UK regulations.
Obtain the necessary certification or documentation from the approved body.
Regulatory requirements for UKCA Marking
Timeline
Device testing, pre-clinical studies, clinical evaluation, design documentation, and labeling will take no more than 5-6 months, whereas notified body review will take 6-10 months.
Regulatory Body
Approved Bodies are appointed by the UK and these only apply to UKCA marking.
Fees
This will depend on many factors – for example, the regulations that apply to your products, the number of products you make, and the number of manufacturing locations you operate.
Validity
The UKCA marking does not have any time limit – it is a declaration made at a point of time. Some certificates that are required for UKCA (as with CE Marking) may have time limits. For example, GAR type examination certificates are valid for a maximum of 10 years.
