EU releases new guidance document for e-labeling

We want you to be aware of a new guidance document that has been released that deals with the issue of e-labeling. MEDDEV 2.14/3 REV 1 released in January 2007 now permits IVD companies whose products are intended for PROFESSIONAL USE ONLY to provide their Instructions for Use (IFU) on different media such as CD, internet, fax, etc. in addition to the traditional paper format. Self-testing products used by "lay persons" are still required to receive a paper IFU.

Even if you do not manufacture an IVD, we expect this guidance may serve as the basis for medical device e-labeling after the new European Medical Device Directive (MDD) is published. In an earlier newsletter, we highlighted the changes to the MDD and noted that this published draft opens the door to provide IFU for devices through electronic means.

Before you celebrate the release of this MEDDEV, you should realize that it makes some important demands of the manufacturer in return for the ability to place an IFU on a CD/DVD or online, for example. We recommend that you read the new MEDDEV carefully. It can be found in the Learning Library section of our website.

As always, we are here to serve you. If you have any questions regarding this MEDDEV, please feel free to contact our US office at +1.512.327.9997 or respond to this email.

Best Regards,

Evangeline Loh, PhD, RAC
Director of Regulatory Affairs