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Letter to the Editor - Devices regulation in the UK

This article was originally published in Clinica

Executive Summary

Two weeks ago, we printed a feature in which some of the UK devices sector's key players decried the lower regulatory profile of their industry in the year and a half since devices and pharma regulation were merged under the all-embracing Medicines and Healthcare products Regulatory Agency (MHRA). On pages 4-8 of Clinica No 1133, interested and concerned parties - MP Ian Gibson, BIVDA (for the diagnostics industry), and the BHTA among them - bemoaned the decision not to install a dedicated head of UK devices regulation. Some observers considered that credible reasons for this were not given at the inception of the MHRA, and are no less reassured 18 months later. We approached MHRA chief executive Professor Kent Woods for his comments on the debate that has emerged, but internal MHRA procedures prevented him from talking to us. Here, he gives a written response.

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