Time To Comment On ‘Bold New Regulatory Regime’ For UK
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.
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The MHRA’s efforts to give the UK a nimble, responsive, innovation-facing medtech regulatory system earnt high marks from Bristows’ Alex Denoon, who assessed the opportunity at hand during the MedTech Summit.
All eyes were on the European Commission in January as it edged closer to adopting new legislation that will see the Medical Device Regulation transition deadlines extended.
Amending the MDR to stem the flow of medtech products being withdrawn from the market has long been seen as urgent. It looks like the EU is keeping its foot on the accelerator to adopt its latest proposal despite concerns raised about the text.