UK Publishes Medical Device No-Deal Brexit Contingency Legislation
The UK has taken the critical step of asking Parliament to approve legislation to future-proof the regulation of medical devices in event of a no-deal Brexit. The proposed new legislation also introduces the new EU requirements contained in the Medical Device and IVD Regulations into national law.
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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.