Medtech Industry’s Wishlist For MHRA’s New UK Regulatory Structure
Convergence with EU regulation, enhanced patient safety and speedy delivery of innovation preoccupy UK medtechs going into 2022
The UK's medtech regulatory consultation has closed and the MHRA must now assess the views of stakeholders on the 465 questions designed to help shape the foundations of a future-proofed regulatory system. But time is tight, as speakers at the ABHI’s annual regulatory conference were at pains to stress.
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European Regulatory Roundup 2021: Extensive Reshaping Of Underlying Medical Device And IVD Structures
2021 witnessed a landmark event in May when the new Medical Device Regulation first applied. The medtech sector will experience a similar milestone this year with the new IVD Regulation coming into force in some four months' time. Medtech Insight reflects on the broad and complex swathe of changes that took place in 2021, putting industry under considerable pressure, and predicts no let-up this year.
Innovative device access pathways are on the agenda of both NICE and the MHRA, but the UK regulator’s new chief safety officer stresses that patient safety first and foremost will shape its work programs in the post-EU era.
The pressing circumstances created by the ongoing COVID-19 pandemic has resulted in the commission not only accepting compliance delays for some IVDs, but also longer transitional provisions than expected.