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Gagliardi and her Canadian colleagues must be commended for calling a spade a spade: “there may be little point in solely educating or incentivising individual physicians to report adverse medical device events unless environmental conditions are conducive to doing so”.(1) “Environmental conditions” being “healthcare system capacity and industry responsiveness”.(1) The French state of affairs illustrates the latter is not about unresponsiveness but deliberate obstructions.
First, in March 2017, after serial warning letters, the French regulatory agency required withdrawal of YSY Medical’s medical devices within a 6 months delay as devices have been marketed without CE marking (Conformité Européenne _European Conformity, in 1985 France was a leader in the Union_ which is about basic safety standards (eg. no explosion, no electrocution …). YSY Medical challenged the decision before a regional administrative court which: a) considered the topic was in its jurisdiction; b) issued an emergency ruling to suspend the Agency’s decision. The Conseil d’Etat, France’s highest court, confirmed the ruling in 2018.(2)
Second, after a suit by the Snitem (National Union of Medical Technologies Industries) and Medtech (an association of 40 companies), the Conseil d’Etat just cancelled a decree (#1716. 13 Dec 2016) requiring a summary of product characteristics for class III and implantable devices.
However, France is improving. In 2009, the Agency’s director wrote “...
However, France is improving. In 2009, the Agency’s director wrote “rapid obsolescene of the products ... is hardly compatible with the delay necessary for clinical trials, particularly morbidity-mortality data.” and recommended “predictive equivalence, the check of the results of the specific test Bench”.(3)
The weak regulation of medical devices, for both efficacy and safety, is an exception in the healthcare system. Exceptions in health never benefit to patients.
1 Gagliardi AR, Ducey A, Lehoux P et al. Factors influencing the reporting of adverse medical device events: qualitative interviews with physicians about higher risk implantable devices. BMJ Qual Saf 2018;27:190-198.
2 Braillon A. Assessment of medical devices: the Emperor's new clothes. Br J Radiol 2018. Online April 24. doi: 10.1259/bjr.20180242
3 Braillon A. Medical devices and the approval processes: United States vs France. Arch Intern Med. 2010;170:2040-1.