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