Intended for healthcare professionals


UK medical device regulation is criticised as both cumbersome and inadequate

BMJ 2012; 344 doi: (Published 17 February 2012) Cite this as: BMJ 2012;344:e1202
  1. Geoff Watts
  1. 1London

Medical device regulations were criticised last week by manufacturers who make devices and doctors who use them.

At a press briefing on 16 February, manufacturers said the regulations were unnecessarily cumbersome, while doctors criticised them for being inadequate and subject to conflicts of interest. The recent breast implant affair may have brought the issue to public attention, but medical professionals and manufacturers alike say they have been questioning the system for years.

At the briefing organised by the independently funded Science Media Centre, Stephen O’Connor, who works for a medical equipment manufacturer, pointed out that it can take 18 months to get approval for a study. Clinical trials must be agreed by national …

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