In a significant move towards a new regulatory framework for medical devices in Great Britain, the Medicines and Healthcare products Regulatory Agency has announced a proposed framework for international recognition of medical devices. This initiative aims to protect public health, ensure access to MedTech innovations, and maintain an attractive market for the industry.
The MHRA's statement of policy intent, published on 21 May 2024, outlines how the UK Government intends to recognize regulatory approvals from Australia, Canada, the European Union, and the United States of America, depending on device type, class, and prior approval. This proposed framework is designed to ensure safe access to quality-assured medical devices while reducing the duplication of assessments by comparable regulators, allowing resources to be focused on more innovative products that benefit patient health.
In addition to the countries mentioned above, the MHRA is actively reviewing the list of comparable regulator countries and is engaged in discussions with the Pharmaceuticals and Medical Devices Agency to explore the recognition of medical device approvals from Japan. This ongoing effort demonstrates the MHRA's commitment to expanding the scope of international collaboration and streamlining the regulatory process for medical devices.
The statement of policy intent serves as a valuable guide for manufacturers, enabling them to start considering whether their devices will be eligible for the proposed alternative routes to market. By sharing this draft policy, the MHRA aims to provide greater clarity about its future direction and its goal of simplifying regulatory approvals where it is safe to do so.
Dr Laura Squire, Chief Quality and Access Officer of the MHRA, emphasized the importance of this announcement, stating, "Today's announcement is an important step forward towards a robust MedTech regulatory framework that prioritises patient safety, gives patients access to the medical devices they need and ensures the UK remains an attractive market for medical technology innovators."
While the proposed framework is still in draft form, it is expected to be integral to the future core regulations once finalized. The MHRA remains fully committed to the UKCA marking for medical devices and continues to expand capacity in UK Approved Bodies to ensure that UKCA marking supports safe and earlier access to the most innovative and transformative medical products.
The MHRA's proactive approach to international recognition of medical devices demonstrates its dedication to fostering a regulatory environment that prioritizes patient safety, encourages innovation, and maintains the UK's position as an attractive market for the MedTech industry. By working closely with comparable regulators and engaging in active discussions with agencies like the PMDA, the MHRA is taking significant strides towards a more efficient and collaborative global regulatory landscape for medical devices.
As the MHRA continues to refine and develop the proposed framework, stakeholders in the MedTech industry can look forward to a more streamlined and harmonized regulatory process that will ultimately benefit patients, healthcare providers, and innovators alike. The MHRA's commitment to striking a balance between patient safety and access to innovative medical devices is a testament to its role as a leading regulatory agency in the global healthcare landscape.
