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Getting a CE Mark could get tougher

on February 22, 2012 Source:

Last year, Center For Devices and Radiological Health Director Jeffrey Shuren created some ripples in the European Union when he suggested that unlike in Europe, the U.S. Food and Drug Administration doesn’t treat patients like guinea pigs.

The remark was in response to growing criticisms that compared to Europe, FDA moves at a snail’s pace in approving devices, hurting the business prospects of U.S. companies.

Now, after the French breast implant scandal, some in Europe appear to be wanting to mimic FDA’s approach. Reuters reported Thursday that the European Union’s Health and Consumer Affairs Commissioner John Dalli wants EU countries to strengthen safety controls on high-risk medical devices by using “spot checks on products and manufacturing facilities,” something that the FDA does here in America.

French government authorities are also seeking tighter regulations, arguing that the EU’s laws relating to medical devices “must be radically redrafted,” Reuters reported.

But one consultant cardiologist at the Telford Health Authority in particular had some sharp words about EU’s medical device regulatory regime, especially the private companies called Notified Bodies that are authorized to provide the CE Mark. As Reuters noted:

Peter Wilmshurst, a consultant cardiologist at Shrewsbury and Telford Health Authority, who also spoke at Thursday’s briefing, was highly critical of the European system, which he said encouraged medical device makers to “shop around” to find a Notified Body most likely to give them “the easiest ride.”

“The Notified Bodies are not working for patients, or for the European Union, they are working for the companies (who make the devices),” he said. “Therefore they have an incentive to get products through because if they’re seen to be an obstructive Notified Body, then they may not get work in the future.”

Wilmshurst said he’d like to see Europe’s system changed completely so medical devices were regulated by a single central and accountable body like the Food and Drug Administration, which regulates devices and medicines in the United States.

Getting a CE Mark is a relatively quick and easy process, and many U.S. companies have for several years introduced their products first in Europe before performing the clinical trials the FDA requires for commercialization domestically.

If Europe goes the way of the U.S., and it likely will not happen overnight, it will no doubt create additional burden for device manufacturers looking to commercialize quickly.

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