BSI launches new fast track program for medical device CE marking

29 September 2008

Quality management systems registrar BSI has launched a new fast track program, called CE-45, that expedites the review process in which most reviews are completed in 45 working days for medical devices headed to the European markets.

The new program builds on a similar program launched last year called CE-90, in which dossier reviews are finished within 90 working days. BSI is committed to providing programs that combine speed and predictability with experience, integrity, independence and reliability.

“There are many Notified Bodies, but the design dossier review process is not always clear and transparent to the medical device manufacturer,” said Paul Brooks, Vice President and Country Manager of BSI Product Services Healthcare.

“In the final step of the launch, CE Marking is the only thing standing between the manufacturer and access to over 400 million citizens in the European market, so it is a critical part of launching their product in Europe. They want the process to be predictable, thorough and fast as possible.”

Brooks, who is serving a three-year term on the RAPS Board of Directors, quickly noted that BSI does not guarantee a CE Marking certificate in 45 or 90 days but the goal is to complete the review process with either a positive or negative recommendation. Some products require the use of outside agencies, such as medicinal or animal tissue products, so they may not be eligible for these programs.

“We can ensure open communication with our customers and dynamic feedback to help them meet their goals, but we do not cut any corners or promise anything we cannot deliver,” added Brooks.

BSI created the New CE-45 FastTrack Program for when every moment counts in the final phase of getting medical devices to European markets, Brooks said, delineating the benefits that CE-45 provides: CE Marking for medical devices; Reviews completed in 45 working days; Knowledgeable product experts; Dynamic, two-way communication; and A technically advanced environment.

BSI has been investing in product experts, Brooks said, noting that they have recruited top-notch people from the industry to help implement this new service. Brooks added that both CE-45 and CE-90 are the result of BSI’s responsiveness to the marketplace.

“We have been listening to our customers. We have been hearing what their problems, issues, and expectations are, and these two services are a direct result of that. CE-90 was the first step last September to make the process more predictable and more transparent for medical device manufacturers. CE-45 is the next initiative, but it is not the end of the story by any means. We are working on many other initiatives that put BSI’s customers at the center of what we do.”

“We understand their needs; we understand what they require from a Notified Body, and we are delivering that in the hopes of exceeding those expectations.”

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