Jan 1, 2007
A new guidance document 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.
We note that there is considerable change in the world of harmonized standards.
The start of 2012 brings substantial news in the world of European guidance (MEDDEV) documents and one regulation. The European Medical Device Expert Group (MDEG) has released four revised MEDDEVs while adding three brand new MEDDEV documents to the EU Commission Web site, plus a guidance document on standalone software devices. These guidance documents represent EU consensus positions on a multitude of topics, though are not legally binding.
A brief discussion on the major changes follows with further resources below.
MEDDEV 2.7/4 on clinical investigations is available on the European Commission website, and also