Brexit: Will UK Now Stockpile Devices? And Is It Certain The Country Will Continue With MDR?
UK starts to discuss emergency measures around devices as no-deal Brexit concerns mount. But it is still looking like the UK will continue to implement the Medical Device Regulation, in the short-term at least. Will it be a different matter for the IVD Regulation?
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It looks as if the EU medtech regulatory system could survive intact in the UK, given terms of the UK blueprint for its future relationship with the EU after separation. But a storm of controversy must be navigated first.
The UK Department of Health's new system of medical device procurement for the NHS went live in May. What was the Future Operating Model (FOM) is now simply the "Operating Model." But there are yet to be any tenders under a system that supposedly champions value and total ownership. UK industry wants to believe it, but will it happen? And will Brexit get in the way?
The highest risk IVDs are due to receive an extra layer of regulatory scrutiny in the EU. But it is taking a long time to set up the structures needed.