Medtech Regulatory Affairs: Is It Time For More Transparency In Europe?

Take a look at this article, published in MedCity News and referenced widely in online media over the past few days. It’s something you’ll not see in Europe, namely reporting of a public “naming and shaming” (aka a citing) of a medical device manufacturer for a variety of misdemeanours, judged by FDA to be worthy of a warning letter.

The list of failings is actually pretty minor and looks like the sort of thing your average auditor would pick up on either side of the pond, but what’s striking is the openness of it all under presumably the freedom of information rules that apply stateside.

So, the nitty gritty here is whether the publication of this dirty laundry is a good thing or bad. Does it act as a deterrent for companies tempted to short cut certain requirements? In other words does the threat of a public slapping make people concentrate. Well, seemingly not in this case, which looks more like oversights rather than deliberate acts.

However, given the slightly cosy relationship between EU notified bodies and their “customers”, maybe a move to greater public citability would provide reassurance for a public and media who appears to have little faith in the current regulatory provisions.

What do you think? Contact us here and tell us.

Source: MedCity News