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Medical Device Approvals: UK Regulator Proposes Recognizing International Standards

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Medical device companies with authorizations from certain regions, including the EU and the U.S., will be able to use their existing approvals to access the Great Britain market under a new policy announced by the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA). This proposed framework is part of broader changes to medical device regulations in Great Britain, set to take effect next year, following the country’s exit from the European Union (Brexit).

Before Brexit, companies used CE marks, which cover the EU, to bring medical devices to market in the United Kingdom (UK) However, Brexit necessitated a rethinking of medical device pathways, leading the MHRA to propose this new framework. Under the current policy, the MHRA continues to recognize CE marks, with this arrangement potentially remaining in place until 2030. Looking ahead, the MHRA aims to expand its medtech regulatory reliance program to include approvals from authorities beyond the EU.

In a recent statement of policy intent, the MHRA outlined its proposal to recognize regulators in Australia, Canada, the EU, and the U.S. as comparable agencies. Additionally, the agency is in active discussions with Japan’s Pharmaceuticals and Medical Devices Agency regarding the recognition of Japanese medical device approvals. This proposed framework would enable companies with authorizations from these comparable agencies to use their approvals to reduce the evidence needed to sell their devices in Great Britain, with some exceptions, such as custom-made devices.

MHRA Streamlines Market Entry for Medical Devices with New Evidence and Recognition Pathways

The specific requirements for evidence will vary depending on the type of device. For example, some Class I devices and Class A diagnostics may be allowed to enter the market based on a manufacturer’s declaration of an appropriate quality management system. Manufacturers of higher-risk medical devices will need to provide more information but will still face lower barriers to entry compared to seeking a UKCA mark, the U.K. equivalent of the EU’s CE mark.

Companies using the international recognition pathway will need to meet additional requirements, such as English language labeling and packaging and appointing a U.K. responsible person. Despite the streamlined process, the MHRA will retain the authority to reject applications if the provided evidence is deemed insufficiently robust.

The MHRA is currently developing the operational aspects of this framework in collaboration with industry and other stakeholders. This includes finalizing details on post-market surveillance and change assessment processes. The agency is testing the framework across a range of devices of all classifications and types to establish a robust and effective process. The goal is to open these international recognition pathways once the new medtech regulations come into force.

Medical Device

MHRA to Recognize International Approvals, Streamlining Medical Device Market Access in Great Britain

The recognition of international approvals is a significant step in the MHRA’s efforts to streamline the regulatory process for medical devices in Great Britain. By leveraging approvals from trusted international regulators, the MHRA aims to reduce the regulatory burden on companies while maintaining high standards of safety and efficacy for medical devices.

The proposed framework reflects the MHRA’s commitment to adapting to the post-Brexit regulatory landscape and ensuring that the U.K. remains an attractive market for medical device companies. The recognition of approvals from Australia, Canada, the EU, the U.S., and potentially Japan, will provide companies with greater flexibility and reduce the time and resources needed to bring their products to the Great Britain market.

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In conclusion, the MHRA’s proposed policy to recognize medical device approvals from comparable regulators marks a significant shift in the regulatory landscape for medical devices in Great Britain. This framework aims to facilitate market access for companies with existing approvals from trusted international authorities, reducing the regulatory burden while maintaining high standards of safety and efficacy. The MHRA is working closely with industry and other stakeholders to finalize the operational details and ensure the framework’s successful implementation, intending to open international recognition pathways alongside the new medtech regulations next year.

 

Resource: Medicines and Healthcare Products Regulatory Agency, May 21, 2024

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