The Future of Medical Device Compliance in a Post-Brexit UK

The healthcare industry in the United Kingdom is navigating significant changes in the wake of Brexit. Among the many challenges posed by the UK’s departure from the European Union, the shift in medical device regulations has emerged as a critical focus area. Ensuring compliance with these regulations is not only essential for market access but also for safeguarding patient safety and driving innovation.

Brexit has created a dynamic regulatory environment. While these changes are daunting for some, they provide a unique opportunity for the UK to refine its regulatory framework and assert leadership in global healthcare innovation. This article will address the history, present state, and future of medical device compliance in the UK.

Overview of the Medical Device Regulatory Framework Prior to Brexit

Before Brexit, the United Kingdom adhered to the European Union’s regulatory framework for medical devices. This system was governed by three key directives:

1. The Medical Devices Directive (MDD, 93/42/EEC): Regulated general medical devices.
2. The Active Implantable Medical Devices Directive (AIMDD, 90/385/EEC): Focused on devices such as pacemakers and implantable defibrillators.
3. The In Vitro Diagnostic Medical Devices Directive (IVDD, 98/79/EC): Covered diagnostic devices like blood glucose monitors and pregnancy tests.

To market a medical device in the EU and UK, manufacturers had to obtain a CE mark, which signified compliance with safety and performance requirements outlined in the directives. This process involved conformity assessment procedures, conducted by a Notified Body—an independent organisation that is designated and authorised to evaluate devices against the EU requirements above. The CE marking allowed seamless access to the EU and UK market, presenting a streamlined approach for manufacturers operating within the single market system.

The framework was designed to ensure uniformity, creating confidence in the safety and efficacy of medical devices. It also simplified market access, reducing barriers for companies seeking to expand across multiple countries using one set of requirements.

Role of the MHRA

In this pre-Brexit era, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) acted as a national regulator but operated within the EU framework. Its responsibilities included:

• Overseeing the registration of medical devices.
• Monitoring adverse events through a centralised EU reporting system.
• Ensuring compliance with EU directives via market surveillance activities.

The MHRA worked collaboratively with EU entities, ensuring that UK manufacturers were seamlessly integrated into the broader European market.

The Regulatory Shift Post-Brexit

The Transition from EU MDR to UK MDR

The UK’s withdrawal from the EU prompted the adoption of the UK Medical Device Regulations (UK MDR), which retained the directives that we mentioned above as UK law.

The shift allows the UK to tailor its regulatory framework to its unique needs. While maintaining alignment with global standards, the UK MDR aims to foster innovation, improve patient outcomes, and ensure stringent safety measures.

Key Differences in the UK MDR

• UKCA Marking: Mandatory for devices in Great Britain after June 30, 2024, that claim conformity to UK MDR.
• Device Registration: Direct registration with the MHRA for oversight.
• Local Conformity Assessments: Evaluations conducted by UK-approved bodies rather than EU NBs.
• UK Responsible Person (UKRP): Required for non-UK manufacturers; local manufacturers can act accordingly.

The UK MDR also emphasises clarity in guidance, reducing ambiguity and facilitating smoother compliance processes for manufacturers.

The Current Status of the Medical Device Regulatory Framework

Transition Periods and Deadlines

To ease the regulatory transition, the UK permitted continued use of CE-marked devices in line with the transitional arrangements below:

• General medical devices compliant with EU MDD or AIMDD can be placed on the Great Britain market up until the sooner of expiry of certificate or June 30, 2028.
• In vitro diagnostic medical devices (IVDs) compliant with IVDD can be placed on the Great Britain market up until the sooner of expiry of certificate or June 30, 2030.
• General medical devices including custom-made devices compliant with EU MDR and IVDs compliant with EU IVDR can be placed on the Great Britain market up until June 30, 2030.

Conclusion

The post-Brexit era represents a transformative period for medical device compliance in the UK. As the MHRA continues to refine the UK MDR, the emphasis on balancing safety, efficiency, and innovation will be crucial in cementing the UK’s role as a global leader in healthcare regulation.

Medical device manufacturers will benefit from remaining up to date on the development of the medical device regulatory reform. The road ahead requires collaboration, adaptability, and a commitment to patient safety and industry excellence.

Given what is going on in the EU at the moment, the UK may hold fire a bit to see what the final outcome of that will be in order to try and avoid a miniature version of the complexity we’re seeing in the EU.

This article has been authored by Adam Isaacs Rae of The Other Consultants. Adam is a medical device consultant and qualified lead auditor who works with certification bodies.

“I take pride in becoming trusted partner delivering pragmatic and risk-based advice to enable organisations place safe and effective devices on the market, while considering their business goals. Regulatory consultancies must be mindful of the cost of compliance we create for manufacturers, and that remains one of my core values.”