A new UK industry body designed to help medical device regulators navigate the new legal landscape of a post-Brexit Britain has launched with backing from 11 companies.
The UK Association for Medical Device Approved Bodies, known as Team-AB, was initially formed at the end of 2023, with the industry body announcing its official launch today (19 February, 2024). The group has said that its aim is to represent medical device companies in dealings with stakeholder groups such as the Medicines and Healthcare Products Regulatory Agency (MHRA) and industry trade associations.
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The new body has launched with backing from 11 medical device certification bodies ranging from BSI Assurance to the UK arms of German equipment testing companies, TUV Rheinland and TÜV SÜD. The body kicked off its first-ever statement by announcing Monisha Phillips, head of Approved Body at TÜV SÜD and Vishal Thakker, head of UK Approved Body at BSI Assurance as co-presidents of Team-AB going into its first year.
Phillips said: “At a time when the UK regulatory landscape is evolving and expecting to undergo significant changes, Team AB will offer an opportunity to bring consistency of interpretation of requirements across Approved Bodies that will benefit manufacturers and patients alike. I am excited and honoured to be involved in the creation of this group.”
This year is set to be somewhat of a tumultuous year for the UK medical devices market, as the country has already begun to replace the already established European Union CE marking, with its own UKCA mark, intended as the national equivalent to the certification following the country’s exit from the EU.
It follows after the UK government’s Department for Health and Social Care announced that it would be spending £10m ($12.5m) as part of a funding initiative intended to rush a series of medical devices to market in hopes of better-equipped UK National Health Service.
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By GlobalDataLaura Squire, chief healthcare quality and access officer at the MHRA, said: “The growth in Approved Body capacity is great news but it does make the job of ensuring consistency a little harder.
I am delighted, therefore, to see the formation of Team AB. We are at a point of real opportunity in the UK – we know that consistency and clarity of requirements matter to the medical device industry and are essential for ensuring the right products get to UK patients when they need them. I really look forward to working together with Team AB to achieve that goal.”
