Selling Diagnostic Testing Services in the EU

Many of our US-based diagnostic testing clients are having Allied help them move into the EU marketplace

In order to commercialize in vitro diagnostic (IVD) in the European Union, a CE Mark certificate is needed. This certification verifies that a device meets all regulatory requirements for IVDs, which recently changed under the new In Vitro Diagnostic Regulation (IVDR 2017/746).

It is estimated that 80% of the current self-certified IVDs must be reclassified to require Notified Body involvement under the IVDR.

IVDs that are up-classified from self-certified to require Notified Body involvement will need a Notified Body-issued IVDR certificate on the date of application to continue to market the product.

Learn how TAGmedica and our partner Titan Solutions can help by checking out our article CE Mark Process for In Vitro Diagnostic (IVD) Devices

About Author
Brian Butler
Brian Butler

Brian Butler is vice president of business development for The Allied Group, a leading provider of marketing and fulfillment programs for the life science, healthcare, education and financial services industries. He is the author of two books, Find ‘Em, Get ‘Em, Keep ‘Em—Proven Strategies for Attracting, Acquiring and Retaining the Right Customers and the recently released In Search of…Customers!, both published by Outskirts Press. Brian has given numerous keynote addresses and presentations for organizations that include AARP, IBM, One Communications, and Atlas Travel International. He holds a BS in marketing from The University of Bridgeport, where he attended school on a two-sport athletic scholarship, and an MBA from Century University. He is a lifelong resident of Rhode Island.

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