UKCA Marking Debate Moves To Next Level: All Eyes On The MHRA

Industry is concerned about the UK regulator’s ability to create the certainty needed for a successful medtech market

The MHRA is under pressure to deliver a new sovereign devices regulatory system in the tightest of timelines for the post-Brexit UK market. It has had no lack of support in this endeavor from system users, but industry is now keen to see the regulator deliver on its two-year plan issued in 2021, says the ABHI’s Phil Brown, in this first part of a two-part industry view of future UK needs.

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Patience and appreciation of the challenges that Brexit has set for the Medicines and Healthcare products Regulatory Agency (MHRA) have been hard wired into the UK devices industry. It too has been busy adjusting to the early stages of life outside the EU.

The task of building a new sovereign medtech regulatory system in less than two years, after three decades of largely successful participation in the EU system of conformity assessment and...

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