ARTICLE SUMMARY:
The UK Medicines and Healthcare products Regulatory Agency proposes doubling or tripling device regulatory notification and registration fees in the UK next year. Excerpted from Pathways' Picks September 7: Fee Watch, Software Guides, and More.
Device regulatory notification and registration fees in UK would double or even triple next year under a proposal from the UK Medicines and Healthcare products Regulatory Agency. MHRA also proposed to add 22 new drug and device fee categories, including fees for device clinical investigation consultations with the agency and linked to the submission of IVD performance reports. MHRA published its proposal last week to recover cost shortfalls, noting that it hasn’t updated drug fees since 2016/2017 and device fees since 2017/2018. The proposal, which would take effect in April 2023, also comes as MHRA is preparing to transition to a new regulatory structure for devices and IVDs distinct from the EU framework. “In recent years there has been substantial technological progress in the field of medical devices and increased rigor is required in order to accommodate the growing complexity of modern devices,” the agency states. “This requires the MHRA to extend scrutiny of these devices, which is more resource intensive and time consuming.”
MHRA’s overarching proposal is to enact an across-the-board 10% fee increase, to add on additional cuts to 61 fee categories that are “significantly under-recovering,” and establish the 22 new fees. In addition to the fees for device and drug submissions, there are significant increases and new fees floated for the designation and transition of “Approved Bodies” that will be tasked with assessing devices under the UK’s new regulations. Public comments on the consultation are due November 23.
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