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.
The Medicines and Healthcare products Regulatory Agency (MHRA) consultation on the role and shape of the UK’s post-Brexit medical devices regulatory landscape is exactly halfway through the 10 weeks given. In a perfect world, the responses would be graded, analyzed and factored into legislation that is scheduled for release as a draft instrument in April 2022.
That would give 15 months for the legislation to get through parliament, be put in place and working at full...
Speakers at a recent UK medtech outlook conference voiced optimism about the sector’s prospects, but warned that cost burdens, over-regulation and lengthy processes will impede the capacity of local SMEs to innovate. Only 10% of NHS procured medtech comes from UK manufacturers.
Roche aims to grow its diagnostics sales by mid to high single digits, said CEO of Roche Diagnostics Matt Sause. The company unveiled the Axelios synthesis and sequencing solution and discussed its “long-term commitment” to China, as well as its business strategy for the next five years.
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.
