Navigating the Post-Brexit Landscape for Medical Devices: Key Updates and Opportunities

The medical device market in the UK has experienced significant changes since Brexit, introducing new regulatory requirements and opportunities. This article provides an overview of the current landscape, focusing on the introduction of UK Conformity Assessed (UKCA) marking, and its implications for market access.

Introduction of UKCA Marking

Post-Brexit, the UK introduced the UKCA marking to replace the European CE marking for products entering the UK market. This new marking system represents a critical shift, requiring manufacturers to adapt to ensure compliance and market access. The UKCA marking applies to most goods previously subject to the CE marking, including medical devices.

UK Medical Devices Regulations (UK MDR)

The UK MDR 2002 remains a foundation of the regulatory framework for medical devices in the UK. This regulation closely aligns with key EU Directives:

• Medical Device Directive 93/42/EEC (MDD)

• Active Implantable Medical Device Directive 90/385/EEC (AIMDD)

• In Vitro Diagnostic Directive 98/97/EC (IVDD)

These similarities make it easier for manufacturers already familiar with EU rules.

Regulatory Separation

Since Brexit, regulatory requirements for Northern Ireland and the rest of the UK have diverged. Northern Ireland continues to follow the EU Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostics Regulation (IVDR) 2017/746, while the rest of the UK follows the UK MDR. Despite this separation, both regions are overseen by the Medicines and Healthcare products Regulatory Agency (MHRA).

Market Share Insights

The global medical device market is dominated by the United States, holding a 46.6% share. The European Union follows with a 26.4% share, while the UK commands a 10.1% share. Notably, the UK has the third-largest medical device market in Europe and the sixth-largest globally, with an annual turnover of approximately $33 billion (£26 billion).

Utilising CE Marking for UK Market Entry

Manufacturers with CE marked devices can leverage transitional timeframes to switch to UKCA marking. However, compliance with EU MDR or IVDR is required for Class I and general In Vitro diagnostics (IVDs) that have been up classified. This transition period allows manufacturers to continue accessing the UK market while adapting to new requirements.

UKCA Marking

UKCA accreditation offers several advantages:

• Cost and Time Efficiency: Particularly beneficial for low-risk Class I medical devices and general IVDs.

• Higher-Risk Devices: Class I sterile, measuring, IIa, IIb, and III devices require review by an Approved Body for UKCA marking.

  
  

As of July 2024, nine UK Approved Bodies are certified to provide UKCA accreditation, ensuring that higher-risk devices meet the stringent regulatory standards for market access.

UK Responsible Person (UKRP)

Non-UK manufacturers must appoint a UK Responsible Person (UKRP) to register devices and add UKRP details on labels for UK market access. This role is crucial for maintaining compliance and ensuring the traceability of medical devices within the UK market.

Conclusion

The UK medical device market continues to offer significant growth opportunities despite the complexities introduced by new regulatory requirements. Staying updated with UK regulations is essential for successful market entry and leveraging the UK's substantial market potential. Manufacturers must remain vigilant and adaptable to navigate this landscape effectively.

Information from "Unlocking the UK" paper from Medical Plastics News Issue 74 page 16 + 17.