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EU Sales Lagging?  
Maybe It’s Your Website

by Glen Emelock & Elizabeth Prescott, The CRO Group

Does your company have a website yet promoting your products? One of the latest trends for would-be international customers is to investigate product specifications, availability, and pricing…over the Internet. When purchasing agents browse your company website, what kind of information do they get? Most company websites have a downloadable catalog, brief product descriptions, contact info and maybe an order form. Few have product specifications or pricing and availability, information on conformity certification, or can take orders dynamically. But hold everything!  FDA considers websites operated from the USA displaying medical device information to be regulated as advertising, which in turn, is regulated as labeling.  The CRO Group has helped several clients over the past year improve their web sites for a European sales boost and stay within FDA unwritten guidelines.

FDA's main concerns are that the promotion of a product does not go beyond the approved or cleared label claims in the 510(k) or PMA.  The latest trend of informing would be consumers of new, unapproved uses for products is something the FDA is not taking lightly.   On the other side of the pond, so far, the EU has not issued any concentrations or proposals concerning advertising regulations via the Internet.

In addition to achieving a dynamic e-commerce site, The CRO Group can help you use your website to actually achieve compliance with several regulations, including the USA MDR (medical device reporting) and EU Vigilance requirements, as well as establish a technical support center, and provide a portal for customer feedback to the design control process.   And, as  FDA is monitoring device manufacturer websites (at least they say they are doing this), we provide validation protocols and report results in conformance with applicable standards in the event this information is requested during an inspection.

If you say, "well, we have CE mark, and our European sales are the same as before we achieved this," then you are a prime candidate for our website improvement program.  Your website should be viewed as a 24/7 (24 hours a day, 7 days a week) sales and technical support center, and should be equipped to provide all sorts of helpful information as well as take in feedback to help keep the quality system working effectively. 

For more information, contact us by clicking here.