MedCity News, the news sheet purporting to cover everything from the world’s core medical cities, has followed the same lines as our piece about future EU medical device legislation(EU falls into regulatory knee-jerk trap in response to PIP scandal), with one of its own. The article, which can be found here, reflects the recent calls from the European Parliament for EU medical device regulations to be toughened up in light of the recent PIP debacle. They’re even suggesting something akin to a PMA process, which we believe would only be partially successful, given the plain reality that most product problems occur far enough down the line that a PMA study would likely not have caught it.
We’re covering this again here, not because it does something more than reinforce the story, but because we’re not advocates for this sort of knee-jerk response to what is admittedly a disaster. We’ve said it before and we’ll say it again. Bringing in tougher legislation to try to catch the rare problematic outlier is not in patients’ interest for two reasons. Firstly it will probably not catch the determined fraudster and second, in the process of trying the rest of the industry will be shackled by a regulatory regime which stifles investment and innovation and therefore slows the advancement of technological solutions to the world’s healthcare challenges.
It’s just nuts to raise the pre-market barriers too high. Of course there are issues needing to be resolved, and it may be counter-intuitive, but the case for heightened post-market surveillance is a strong one.
Source: MedCity News
published: May 7, 2012 in: Regulatory, USA