One problem with answering the question is unlike the U.S., in Europe, no one body is responsible for reviewing all submitted products. In the EU, each member state's health ministry may outsource its review process to independent, mainly private, third party certification organizations called Notified Bodies. U.S. companies then have to hire these organizations - TUV and BSI are two of the big ones assist in the CE marking process which involves quality control audits and product review.

"For instance, say a US company wants to go to Europe, and they choose BSI to be their auditor," says Schorre. "BSI is based in UK. The UK basically authorizes BSI to conduct these audits."


While in theory, all Notified Bodies and the country authorities they answer to treat all applications in a uniform fashion, in fact, there are small differences, and companies can, and do, look for the best fit.

"There's shopping in the sense that companies developing Class 3 products, if it's a controversial product, they'll search for an auditor based in a country where they might have more of a chance of approval," says Schorre.

He gives an example. "Some countries, which I won't name, don't like teeth-whitening products. Some of them feel those products are not medical devices; they're more like a drug. So companies will sometimes say, 'Instead of going to this country to try to getregulatory approval, let's go to a different country.'"

This lack of real-world standardization can have an effect on whether clinical trials are necessary - one of the more time-consuming parts of the approval slog.

Sarah Sorrel, president and founder of Medpass International, a Paris, France-based company that guides mainly U.S. companies looking to open the European market, wrote an article in 2006 in the journal Applied Clinical Trials investigating the differences between EU and U.S. regulations. While the subject is too complex for a simple answer, she does notice that oftentimes European regulators wouldn't demand the randomized, multi-center clinical trials that seriously risky Class 3 products often warranted stateside, because CE markings require demonstration of safety and performance rather than safety and effectiveness as in the U.S. "In our experience," she writes, "CE marking protocols rarely include a study hypothesis and a statistical calculation of sample size even though this is a requirement of the European Standard."

When getting a major medical product approved, she tells DOTmed News that "requirements for clinical data were much less."

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