Medical Devices and the Limits of UK Regulatory Autonomy

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Publication Date August 2021
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Opportunities to diverge from EU rules and approaches, and deliver better outcomes for companies, consumers and patients do exist. However, with its relatively small market size, the UK will struggle to break free entirely from the regulatory pull of larger economies – particularly when it comes to highly regulated products. In the case of medical devices, British patients are more likely to benefit if the UK systematically embraces its position as an Australian-style rule taker, and free-rides on the regulatory innovation and capacity of others. UK companies might also benefit from such an approach, as their device development could be focused on the requirements of large export markets (perhaps especially the US) in the knowledge that doing so would also ensure access to their home market.

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EPRS Briefings: Apr. 2020: EU imports and exports of medical equipment

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