New Qarion e-Labeling Service Allows IVD Medical Device Manufacturers to Place Multilingual User Manuals Online in Europe

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New web-based system allows manufacturers of professional use In Vitro Diagnostic (IVD) medical devices to place their Instructions for Use online in Europe instead of shipping multilingual paper inserts along with the product as previously required.

This is not only environmentally wasteful, inefficient and costly, but it is also often frustrating for users who must navigate large, multilingual documents in very small print to read instructions in their native language.

Emergo Group Inc. and Qarad b.v.b.a. have jointly announced the launch of a new online service that allows In-Vitro Diagnostic companies to place Instructions for Use (IFU) for IVD professional use products online for customers to download instead of putting a paper copy with the device.

The web-based Qarion® IVD e-labeling system, developed by Belgium based consulting firm Qarad b.v.b.a., addresses a long standing problem among IVD manufacturers selling IVD products used by clinical professionals in Europe. Most IVD manufacturers have printed lengthy multilingual manuals that are shipped with the product. Qarad CEO Dirk Stynen notes: "This is not only environmentally wasteful, inefficient and costly, but it is also often frustrating for users who must navigate large, multilingual documents in very small print to read instructions in their native language."

The Qarion system works by allowing IVD manufacturers to print a unique web address and code on product labels that will lead the user to download a PDF version of the IFU in their native language.

Qarion also meets a key European requirement that users be able to request a printed copy of the IFU via a toll-free (freephone) telephone number. Qarion has established a pan-European toll-free network, staffed by multilingual operators, to meet this requirement. Users simply request the manual they want using the code printed on the product label. The implementation of Qarion has been approved by notified bodies.

Stynen notes: "Several IVD companies have tried to develop an in-house e-labeling system but ultimately decided to use the Qarion system because it was a more cost effective way to comply with the requirements in European guidance document MEDDEV 2.14/3 REV 1. Given that they no longer have to print thousands of manuals, they end up saving a lot of money using the service."    

The Qarion system is being represented in Europe by Qarad b.v.b.a., and by Emergo Group Inc. in the rest of the world. Demos can be requested online at http://www.qarion.com

Qarad b.v.b.a. was founded in 2000 in Mol, Belgium and specializes in IVD regulatory consulting. Austin, Texas based Emergo Group, Inc., focuses on medical device regulatory consulting and was founded in 1997.

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CHRIS SCHORRE

Dirk Stynen
Qarad bvba
+32 14 32 38 99
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