BSI Launches New In Vitro Diagnostic CE Marking Service

LONDON, June 14, 2010 - BSI is proud to announce the expansion of its world class Notified Body
CE Marking Services to include the In Vitro Diagnostic (IVD) European
Directive 98/79/EC. This new extension establishes BSI as a full-service
Notified Body supporting all types of devices, encompassing medical, active
implantable and now IVDs. BSI has been accredited with a comprehensive scope
which includes all In Vitro devices listed in Annex II List A (high risk) and
List B (moderate risk) as well as Self Test, which are primarily used by lay
persons.

The In Vitro Diagnostics Directive (IVDD) sets the CE Marking
requirements needed to place IVD medical devices on the European market. In
Vitro Diagnostics includes devices and accessories used to perform tests on
samples; taken away from the body (such as blood, urine, tissue); to help
detect infection; diagnose a medical condition; or prevent disease.

"As technology advances, the divisions between the three Medical Device
Directives becomes finer and products may cross over", explains Paul Brooks,
Vice President BSI Healthcare. "It is essential that a Notified Body can
support clients across all device categories and by extending our scope to
include the IVD Directive, BSI customers can work with one organisation for
all their certification needs."

BSI's IVD Service is built upon the same successful foundation that has
made BSI a leading Notified Body, with a worldwide reputation for delivering
services that blend experience with safety and speed with predictability.
"Our new fully resourced in-house team is one of the most experienced in the
industry", states Sue Spencer, BSI Head of IVD. "Our product experts have an
average 17 years of regulatory and industry experience in IVDs."

BSI is working with two world-leading test laboratories, Paul Ehrlich
Institut in Germany and Sanquin in the Netherlands, to provide Annex II List
A Verification of Manufactured Product testing. Companies using these
laboratories that choose to transfer to BSI can keep their same testing
facilities, allowing for a seamless transition.

Gary Slack, Commercial Director BSI Healthcare adds, "We will be offering
a range of dynamic, informative and complimentary IVD webinars along with
more formal training as part of an excellent program designed to meet the
regulatory demands - now and into the future."

Media Contacts: USA, Linda Vasquez, linda.vasquez at bsigroup.com, www.bsiamerica.com/healthcare, +1(919)-359-0366; UK & Europe, Claire Lynam, Claire.lynam at bsigroup.com, www.bsigroup.com/IVD, +44(0)-8450-765600