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O processo médico da aprovaçã0 do dispositivo do EU começará mais resistente?

por Loren Bonner, DOTmed News Online Editor | May 22, 2013
Paul Teitelbaum
Paul Teitelbaum, managing director with Mesirow Financial's Investment Banking Practice, spoke with DOTmed News about the potential overhaul of the CE mark process in the European Union and its impact on medical device companies here and abroad.

DMN: What's the status of the European CE mark process being overhauled?

PT: We don't know for certain yet that the European CE mark process will be overhauled, and there has been debate about this between the European Parliament and the Commission which oversees medical devices, but there have been issues with medical devices sold into the European market over the past few years that the Parliament is probably trying to address. For example, in 2012 there was a health scandal involving a now-defunct French breast implant company.

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Historically, it has been relatively simple for medical device manufacturers to get the CE Mark. As a result, the market has become flooded with devices, many of which have questionable benefits. Therefore, many believe this was due to happen because the CE Mark process has been essentially an open door for medical devices.

DMN: Briefly, how does the CE process for medical device approval differ from the U.S. FDA process?

PT: For relatively invasive devices, such as implants which are critical to life support or pose a potential risk when being used (“Class III” devices, e.g., an implantable heart pacemaker), the approval process has been relatively similar between the U.S. FDA and CE Mark: companies needed to undergo a PMA process which requires costly clinical trials to demonstrate safety and efficacy. This approval process can take three to five years from the beginning of clinical trials.

For the large portion of devices that have lower risks, generally those that are non- or minimally-invasive ("Class II" devices, such as infusion pumps, some catheters, minimally-invasive surgical tools, etc.), the process has been significantly easier in the EU, whereas the FDA 510k process for these devices frequently requires studies of 25-100 patients, a relatively lengthy review time, and can take 12-18 months.

Contrarily, the European Commission has required significantly less - anywhere from just filing information about the device, to small, quick trials with up to 30 patients, and the process has taken three to six months and at a fraction of the cost of a U.S. 510k.

The U.S. process is also a centralized process - applications all go through the FDA, which has stringent requirements and a backlog of applications being reviewed. On the other hand, the EU process has been a decentralized one where an application could be made through a Notified Body in a given country and some countries have been less stringent than others and certainly less so than the U.S.

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