Brexit: Will UK Now Stockpile Devices? And Is It Certain The Country Will Continue With MDR?
Executive Summary
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?
You may also be interested in...
UK Brexit White Paper Would Keep Medtech Regulatory System – And Testing Just Once – Intact
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.
UK Must Break The Cycle Of Pricing Pressure And Face Up To Medtech Value Needs
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?
EU Regulatory Experts Support Notified Bodies, But Argue For Greater Consistency
Notified bodies have been a pivotal part of the EU medtech regulatory system since it was first launched in the 1990s. Where might they fit within a new medtech regulatory governance structure? Panelists on a recent vodcast grappled with the question.