The IVD extension of scope establishes BSI as a full-service Notified Body for All European Medical Device Directives.
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.
IVDD and CE marking requirements
IVDs are an essential and fast growing part of healthcare industry. 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 will enable customers to work with one organization 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 blends experience with safety and speed with predictability. “Our new fully resourced in-house team is one of the most experienced within the industry, states Sue Spencer, BSI Head of IVD. “Our Product Experts have an average 17 years of regulatory and industry experience covering the full scope of IVD products.”
BSI working with world-leading laboratories
BSI is working with two of the 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—this will enable a smoother and more seamless transition.
Gary Slack, Commercial Director BSI Healthcare adds, “In the near future we will be offering a series of dynamic and informative complimentary IVD webinars along with more formal training courses, ranging from beginner to advanced. We have developed an excellent program that is designed to meet the regulatory demands of this exciting marketplace— now and in the future.”
For further information, please visit www.bsiamerica.com/IVD
