The demise of the Global Harmonization Task Force as a regulator-plus-industry forum for harmonization – or “convergence,” as the cautiously optimistic like to say – was met with little more than silence from the trade associations, but one can be sure the off-the-record discussions were intense. Now with the International Medical Device Regulators Forum coming together, the time has come to ask what the future of international medical device regulation holds.
First let’s examine the obvious. The chatter about demonstrations of efficacy as a requirement for a CE mark has been going on for some time, and the flap over breast implants made by Poly Implant Prosthèse has generated quite a bit of support for tighter scrutiny of devices in Europe. The problems with metal-on-metal hip implants and electrophysiology leads have pushed this agenda, too.
One should bear in mind that elected officials have large patella tendons where such things are concerned, especially when the mainstream media coverage prompts calls from constituents. That has been true in the U.S. for decades and one suspects it is becoming more the case in Europe as well.
European Parliament getting nervous
Don’t believe me? Take a look at the recent vote by a committee of the European Parliament asking the European Commission to perform a more drastic recast of the Medical Device Directives than might have been planned. The Parliament’s April 26 statement includes the request that the Commission impose a system featuring “more stringent checks and product traceability” as well as “a pre-market authorization system” more robust than that in place now.
The statement also notes that the PIP predicament “has shown a malfunctioning at European and national levels, notably a lack of cooperation . . . and a lack of traceability of raw material used for medical devices.” The statement asserts further that the widely reported problems with metal-on-metal hip implants has demonstrated “a failure of the current system of certification of compliance . . . as well as of the controls of the notified bodies and their surveillance by national competent authorities.”
One might also bear in mind the lack of reaction to something said by FDA’s Bram Zuckerman, MD, at CRT 2012. He claimed FDA drives most of the literature on cardiovascular devices, explaining that trials for devices “usually are done frankly because there is an FDA” demanding those trials. He also remarked, “I have a hard time finding CE-mark trials in publications of the first order.” Nobody dissented, and there were quite a few people in the room who were in a position to argue if they disagreed.
Gravitas is great; gravity is better
My working hypothesis on this is ably reflected by the notion of a binary star. If you picture FDA’s and the EU’s regulatory paradigms as two stars orbiting each other – one heavier and more stationary, the other lighter and anything but dominant – it’s difficult to avoid the conclusion that FDA is the more massive of the two, with the obvious implications. Prefer a more complex model that incorporates non-EU initiatives? Perhaps you’d find a depiction of a solar system more to your liking, but I’d point out that the most massive object is always at the center.
Of course the details matter, but let’s not be confused about the overall direction. FDA still outweighs everyone else, and will almost always have its way in a close call. If anyone is going to move anyone else out of their spot in the firmament, it’s not the European Commission, Health Canada, China’s State Food and Drug Administration or anyone else. It’s FDA.