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 an approach based on the pharmaceutical model,3 because devices require a “tinkering” stage during their early development (IDEAL stage 2a) and their performance is often affected by operator learning curves (IDEAL stage 2b).

IDEAL does not call for randomised controlled trials when evaluating devices, but for a logical progression of studies that tackle different questions using different methods as the innovation process develops. Certainly class 3 devices should be rigorously evaluated,4 but a randomised controlled trial too early in development may fail or produce contentious results that are difficult to interpret, for well recognised reasons.5

Much of the discussion is based on a false dichotomy between approval and non-approval. But in many situations the best way to ensure the accumulation of good evidence, minimise risk, and allow innovation would be approval under strictly defined conditions of continuing evaluation in well designed prospective studies. Rare and long term harms cannot be reliably detected by early phase studies or randomised trials. We need a framework of ongoing evaluation alongside innovation, whereby appropriate methods are used at each stage in the product lifecycle, up to and including that of long term surveillance. This could, with great benefit, be developed on an international basis, but much thought will be needed on how to develop the registries and ethical frameworks necessary for essential early phase innovative work to continue without compromising patient safety.


Cite this as: BMJ 2011;342:d3540


  • Competing interests: None declared.


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