UK To Demand 'Responsible Person' Be Physically Located In Country Under No-Deal Brexit
The recent no-deal Brexit notice from the UK government says that companies selling devices in the UK would need a "Responsible Person" in the UK if the firm is not based there. The government clarifies to Medtech Insight that such person must be physically present in the UK, and not simply have an address there.
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The UK government is introducing new registration requirements for medical devices in the event of a no-deal Brexit. They will be rolled out according to the risk class of products. But some fundamental questions have arisen.
The regulation of medicines and medical devices have long worked along parallel, but very different, lines. Now there is increasing pressure for them to also be jointly improved to support innovation.
Unconstrained by having to compromise with other countries’ regulatory approaches, the UK is now seeking views on its proposal for a pioneering and “bold new regulatory regime” for medtech products.