This article explores the reasons behind the introduction of the EU Medical Device (MDR) and In Vitro Diagnostic Devices (IVDR) regulations, the problems that beset them and how COVID-19 finally persuaded the European Commission that a further year’s preparation time for full application of the regulations was necessary.
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Paul Ranson (Morgan Lewis)
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The current regulatory system for medical devices in the UK, as an EU member state, is complex enough without the uncertainties surrounding Brexit. In this article, legal advisor Paul Ranson reviews the current and forthcoming regimes and how Brexit may impact manufacturers and regulators working in this space.