Intended for healthcare professionals


The EU’s system for regulating medical devices

BMJ 2012; 345 doi: (Published 24 October 2012) Cite this as: BMJ 2012;345:e7126
  1. Peter McCulloch, clinical reader in surgery
  1. 1Nuffield Department of Surgical Science, John Radcliffe Hospital, Oxford OX3 9DU, UK
  1. peter.mcculloch{at}

Now is the time for radical change

The regulation of medical devices in the European Union has not had a good year. No sooner was the controversy about metal-on-metal hip prostheses beginning to die down when the PIP (Poly Implant Prosthèse) breast implant scandal came along to further undermine both public and professional confidence in the regulation of devices. In a linked BMJ investigation (doi:10.1136/bmj.e7090),1 Cohen follows up on previous investigations to once again target the weaknesses of Europe’s medical devices regulatory arrangements and ask whether the system is fit for purpose.2 3 The president of the Royal College of Surgeons is among those who have joined the chorus of disapproval.4

A straightforward description of EU device regulation often elicits an incredulous response from clinicians who are unfamiliar with how it works (and that is most of us) and the question “How could this have come about?” The current system, which is based on directives 93/42/EEC, 90/385/EEC, and 98/79/EC, relies on 76 “notified bodies” to evaluate the safety and reliability of clinical devices and issue the “CE mark” that allows a device to be marketed in the EU. These notified bodies are private companies that enter into contracts with …

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