Notified Body Speeds Up CE Mark Reviews

NEWS TRENDS

Some Class III devices can now have their European CE mark reviews completed in 45 working days or less, thanks to a new program launched this fall by a notified body.

In the United States, such speed is unheard of. FDA reviews Class III devices via the premarket approval (PMA) process, which in fiscal year 2006 took, on average, 283 days. But to get on the market in Europe, device companies make submissions to notified bodies, which are private entities that charge a fee.

So, in response to customer demand, notified body BSI Inc. (Reston, VA) introduced a program called CE-45, in which it will complete the review process in 45 days with either a positive or negative recommendation. It does not guarantee a CE mark. Products that require consultation from other agencies, such as drug-device combination products or animal-tissue products, may not be eligible for the program. Products that are “totally novel” are not eligible because they have too much clinical data that need to be reviewed says Paul Brooks, vice president and country manager for BSI Product Services Healthcare.

Brooks says that the firm began a 90-day program last year, and although it was received very well, some clients wanted a process that was even faster.

“A lot rides on getting a predictable, understandable CE marking process,” says Brooks. “CE-90 is very good in that regard, but sometimes time is of the essence and you need an even faster turnaround. And that can buy a lot of credibility for regulatory personnel [within their companies].”

The keys to making the program work, Brooks says, will be device companies providing everything required at the start of the process and maintaining regular communication with the notified body. “If your submission is in order, then it should not be difficult to achieve a resolution within the [45 working day] time frame,” he says. “It rests on the quality of the submission. But at least everyone will know where they stand.”

In order to have adequate resources for the program, BSI has added to its technical review staff, Brooks notes.

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