The UKCA (UK Conformity Assessed) marking has become a mandatory requirement for all medical devices sold in the United Kingdom, effective from January 1, 2023. This shift marks the transition from the previously accepted CE certification to the UKCA marking, as the UK establishes its regulatory framework post-Brexit. For manufacturers seeking to access the UK market, understanding these regulations is critical to ensuring compliance and uninterrupted product distribution.
What is UKCA Marking?
The UKCA marking is a certification that indicates a product meets the health, safety, and environmental protection standards required for sale in the United Kingdom. For medical devices, it replaces the CE mark that was previously recognized under the European regulatory system.
Medical device manufacturers must ensure their products comply with the UK Medical Device Regulation 2002 (UK MDR 2002), which has been in effect since January 1, 2021. This regulation aligns with the previous EU Medical Device Directive (MDD), with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) serving as the primary authority overseeing compliance.
Transition from CE Marking to UKCA Marking
While the CE mark was previously recognized in the UK, the transition to UKCA marking requires manufacturers to adapt their certification processes. Most items that required CE certification under the European system are now subject to UKCA requirements.
The Conformity Assessment Process
The UK Conformity Assessment process is currently under development, with new regulations expected to align with the European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) frameworks. This process is expected to cover:
Clinical Evaluation Reports (CERs): Demonstrating the safety and efficacy of medical devices UKCA Marking through clinical data.
Performance Evaluation Reports (PERs): Assessing the functionality and effectiveness of in vitro diagnostic devices.
To navigate the conformity assessment process, manufacturers are advised to:
Develop an in-house regulatory team or
Engage external consulting experts with experience in UK medical device regulations.
Preparing for UKCA Compliance
Manufacturers planning to sell medical devices in the UK must take proactive steps to ensure compliance with UKCA marking requirements:
Understand the Regulations: Familiarize yourself with the UK MDR 2002 and updates from the MHRA.
Review Product Documentation: Ensure all technical files, clinical evaluations, and performance evaluations meet UK standards.
Identify a UK Responsible Person: Non-UK manufacturers must appoint a UK Responsible Person to oversee compliance and liaise with the MHRA.
Engage with Notified Bodies: If required, work with UK-based approved bodies for conformity assessment.
Stay Updated: Keep track of MHRA updates and new regulations expected to be released.
Anticipated New Regulations
The MHRA is expected to release updated regulations, harmonizing certain aspects of the UK framework with the European MDR and IVDR. These updates are anticipated to provide greater clarity on the UKCA marking requirements, streamlining the conformity assessment process for manufacturers.
Why Early Preparation is Essential
Given the evolving regulatory landscape, manufacturers must act early to avoid delays in accessing the UK market. The UKCA Marking process of preparing documentation, undergoing conformity assessments, and ensuring compliance can be time-intensive. Early engagement with regulatory consultants or establishing an in-house team can provide a significant advantage.
Contact Us for Guidance
Navigating the complexities of the UKCA marking and medical device regulations can be challenging. Our team of regulatory experts is here to help you understand and comply with the requirements. Whether you need guidance on the conformity assessment process, clinical evaluations, or performance evaluations, we offer the expertise and support you need to ensure your products are market-ready.
Reach out to us today to learn more about medical device regulations in the UK and how we can assist in achieving UKCA compliance.
By adapting to these regulations and ensuring compliance with UKCA marking, manufacturers can confidently position their medical devices for success in the UK market.