With so many emails and articles flying around about proposed regulatory changes in Europe, it can be hard to keep up with exactly what's going on. Here's your short story, coffee table version.
In Europe, there have been considerable efforts to increase the scrutiny of medical devices, pretty much ever since the PIP breast implant scandal broke in late 2011. While this has been a long, ongoing process, there has been some recent progress, with the European Parliament anticipated to vote on the latest proposal in late October.
The proposed regulations would subject manufacturers of higher-risk devices to more intensive approval processes than it looked like initially. Under the current amendments, the proposal calls for creation of special notified bodies to assess the highest-risk devices. This is likely to lengthen approval times in Europe, reducing the gap between FDA approval and European approval, which is so often lamented in the US.
Although medical device companies obviously have some objection to this higher scrutiny, this situation could have arguably been worse for them. This proposal is a bit less exacting than the one put forward last spring by the much-maligned rapporteur of the European Parliament's ENVI (Environment, Public Health and Food Safety) committee, Dagmar Roth-Behrendt, which called for premarket authorization (PMA) of high-risk devices partly centralized under the European Medicines Agency (EMA). However, central oversight is thought less flexible as well as more prone to delays. This would have been the ?worst case scenario? recent industry estimates
suggested would add annual costs of ?17.5 million for companies bringing Class III devices to market. Still, industry representatives are less than thrilled with the addition of several new layers of bureaucracy and duplication of oversight. Some fear this plan may ultimately be just as damaging for patient access to innovative technologies.
None of this is going to have an immediate impact on medtech: the current hope is to have this adopted by April 2014 (to sneak it in before the next European Parliament election) with a three-year transition period. So plenty of time for medtech to continue to object?no doubt they?re hoping they?ll have more success than they?ve had so far with the medical device excise tax repeal in the US.