Letters Regulation of medical devices

Wanted: an appropriate evaluation template

BMJ 2011; 342 doi: https://doi.org/10.1136/bmj.d3540 (Published 07 June 2011) Cite this as: BMJ 2011;342:d3540
  1. Peter McCulloch, reader in surgery1
  1. 1Oxford University, Oxford, UK
  1. peter.mcculloch{at}nds.ox.ac.uk

Both US and EU regulatory regimes need to be updated to deal with the myriad new devices, whose invasiveness, capabilities, and potential for harm are hugely greater than they were 20 years ago.1 2 In developing rules for evaluating these devices, however, the development process needs to be taken into account. The IDEAL framework may prove more useful than …

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