PIP Fallout: Unannounced Audits Won’t Wait For New Directive

In short

In an interesting and authoritative update from last week’s RAPS regulatory convergence conference in Seattle, medicaldeviceslegal.com’s Erik Vollebregt has laid out the bare facts about one of the key post-PIP measures discussed during 2012.


Erik’s piece can be found here in full, but what it says in a nutshell is that certain components of a revised Medical devices directive(MDD), due for full implementation in 2014/5 are very likely to go ahead almost immediately. Specifically we’re talking about the unannounced factory visit, which, it is strongly argued, would have been the single measure most likely to have caught the misdemeanors of Poly-Implant Protheses.

Why can this change be brought in so quickly in a world where bureaucracy rules? Because, as we’ve pointed out before, the measure is already written into the existing MDD! So it’s a matter of leaning on notified bodies to make sure they use the tool with appropriate frequency, and also leaning on member states to make sure their notified bodies are fulfilling their obligations. Indeed a new EU commission recommendation on audits and assessments has been published and will be enacted in early 2013.

Now to the “can of worms” which is the nitty gritty of the audit requirements. The audit frequency is defined and variable dependent on certain factors, not least the risk profile of the products in question. But, as Erik Vollebregt points out, the frequency is only really a minimum. Notified bodies will be able to increase it and are unlikely “in the present climate” to find anyone other than the manufacturer complaining. And the manufacturer will be complaining because the manufacturer pays for the audits. But they may likely have almost no recourse.

How much fun is this all going to be?

Still, given the sense of grumbling from the UK’s parliamentary select committee last week that measures were not coming in quickly enough, here’s one that is.

Source: medicaldeviceslegal.com