It’s The Big Day! Anticipated Changes To EU Device Regulations Will Have A Huge Impact

At 12.30 CET today a press conference will be held, chaired by EU commissioner John Dalli.

The subject will be the EU commission’s adoption of a new legal framework governing the regulation of medical devices.

You can follow it live, here.

Oh, and remember this moment, because from the moment the new regulations come into force in 2015 you can be sure things will change. It’s unlikely that the status quo will endure beyond that time, which means the usual picture of (usually American) companies sliding their products onto the EU market by having to jump over the smallest of barriers so to do, will end. It’s likely that higher risk products will be subjected to a whole new level of scrutiny, much closer to a U.S style PMA process. It’s likely that clinical data requirements will ramp upwards and that all data used in support of an approval will find its way into the public domain (it currently doesn’t). It’s likely that the notified body(NB) set-up will be overhauled so companies can no longer pick NBs they perceive as softer or from “softer” countries.

And required post-marketing surveillance measures will be a key focus area as everyone seems to agree that, for implants at least, registries have been the best way of spotting problems.

We’ll stop there. You can play the prediction game yourself for the next hour or so.

We’ll be back later with post-match analysis.