Vibrant IVDs Innovation Climate At Risk From Poor UK Regulatory System Readiness
The spotlight is on IVDs in the post-COVID phase. Innovators in university spin-outs and the established industry have responded with new technologies, creating a vibrant scene. Regulators and reimbursors must not disrupt the momentum, say BIVDA’s regulatory affairs manager Ashleigh Batchen and chief executive Doris-Ann Williams.
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The UK regulator is likely to establish mid-2024 as the new deadline for the standstill period during which CE-marked devices may access the UK market. Compulsory UKCA marking would accordingly also be delayed by a year.
A fourth approved body has been accredited to audit medical device submissions against the UKCA marking. A fifth is thought to be not far behind, but current assumptions are that overall auditing capacity will not be adequate under the forthcoming UK medical device regulations.
The UK’s new medical device regulations remain a work in progress, ahead of the parliamentary process and codification into law in 2023. The ABHI’s Phil Brown says industry will continue to advise the government on how to maximize fully the rare opportunity the UK stands before.