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UKCA Marking Consultants

UKCA marking consultants for medical devices and in vitro diagnostic (IVD) devices play a crucial role in assisting manufacturers in ensuring compliance with UK regulations (MDR 2002) post-Brexit. Here are the important technical areas.


UKCA (UK Conformity Assessment) is the new UK product marking required for medical and In-vitro diagnostic devices sold in Great Britain (England, Scotland, and Wales) after Brexit. It replaces the CE marking that was previously used under EU regulations. I3CGlobal Consultants helps manufacturers navigate the complex regulatory landscape and ensure their devices meet MHRA Certification Body UKCA marking compliance requirements.


  • Consultants specializing in UKCA marking for medical devices and IVDs possess extensive knowledge and experience in regulatory requirements and standards specific to the UK market. They stay updated on any changes in regulations and guidelines, providing manufacturers with accurate and timely advice.


  • Ensuring compliance with technical documentation to demonstrate the safety and efficacy of medical devices and IVDs. Consultants help manufacturers identify the documentation needs, risk analysis, and clinical evaluation, address compliance issues, and implement appropriate strategies.


  • Navigating regulatory requirements can be time-consuming and challenging for manufacturers, especially those unfamiliar with the UK regulatory framework. Consultants streamline the process, helping manufacturers save time and resources by guiding the most efficient pathways to UKCA marking.


  • Consultants assist manufacturers in preparing the necessary documentation, supporting evidence and technical files required for UKCA marking, including DOC, clinical, risk assessments, and quality management system documentation. They ensure that all documentation meets the requirements of UK regulations.


  • Consultants provide support during Onsite audits by UKCA Certification Bodies, helping manufacturers demonstrate compliance with UKCA marking requirements and addressing any issues that may arise during the audit process.


Overall, I3CGlobal and their team of UKCA marking consultants play a vital role in helping manufacturers of medical devices and IVDs navigate the post-Brexit regulatory compliance to bring safe and effective products to market.

Frequently Asked Questions

What is average timeline for UKCA marking?

The average timeline is around 8 months post-submission of the technical documentation.

What is average timeline for preparing the technical documentation?

With the full support of the manufacturer, the consultant team may be able to finish the technical documentation in 3-4 months. In some cases, the implant timeline may extent to another 2 more months.

What is average timeline for completing Biocompatibility testing?

The majority of the tests can be completed in 90 days.

Will the I3CGLOABL team Authorize / Prepare technical file for the clients?

Yes. We prepare the technical documentation for all our customers with assurance. We also submit and answer CB queries.

MDR Technical Documentation Support

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Buy Risk Analysis Procedure & Templates

Very useful for small and medium size medical device manufactures