The Impact of Brexit on Medical Devices and Diagnotics
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New MHRA guidance says the EU CE marking will continue to be used for devices and diagnostics in Great Britain until June 2023, and thereafter a standalone regulatory system will come into place.
Although the EU MDR and IVDR will fall outside the scope of new post-Brexit medtech regulations for Great Britain in 2021, the UK MHRA says it has the chance of developing its own world-leading regulatory regime.
ABHI director of value and access Luella Trickett talks about the importance of real-world evidence in product development and value-based procurement in secondary care in the UK.
Securing a favorable post-Brexit free trade agreement with the US is the principal aim of the UK’s Department for International Trade, and the UK medtech industry is pressing its case for closer business links with its largest non-EU trading partner.
Parliamentary committee meetings on the UK’s devices bill have been postponed as measures to tackle COVID-19 have been moved to center stage.
COVID-19 is of no lesser importance to the UK medtech industry, but attention is now refocusing on Brexit, future regulation and trade deals.
Work has started on UK-only regulations for the medtech and medicines sectors, to ensure that the regulatory framework not only functions but can also react swiftly to needs after the UK leaves the EU. This article is part two of two.
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