Originally
Published IVD Technology April 2003
EDITOR'S PAGE
The Clock is Ticking
During the past few years, the European Union’s IVD Directive has generated a considerable amount of interest and discussion. A lot of that discussion has focused on deciphering the directive itself, trying to understand what it entails and how it will affect the IVD industry. With the December 7, 2003, deadline fast approaching for IVD companies to comply with the directive, the discussion is now more concerned with what companies have to do in order to get their products properly CE marked.
Considering the numerous opportunities the European market offers, doing anything and everything necessary to get products CE marked would presumably be a major priority for IVD manufacturers.
However, the general perception is that companies for the most part are not well prepared to meet the December 7 deadline. Surveys have shown that many companies have not done much to become compliant with the IVD Directive and are consequently scrambling to get their acts together. In fact, some companies may have no idea what they need to do in order to become compliant.
For the rest of this year, IVD Technology will be publishing a series of articles on the IVD Directive. The purpose of this series is to provide IVD companies with information and guidance as to what the compliance requirements are and how to go about becoming compliant. This series will cover a number of topics related to the directive, including quality assurance systems, labeling and language, performance evaluation, risk analysis, technical documentation, traceability, and postmarket vigilance systems.
In this issue, Sue Spencer gives a broad overview of the general requirements of the IVD Directive. In her article, “Tips to Beat the Clock” (page 41), she outlines the most important aspects of the directive which will be further discussed in greater detail in later issues. In addition, Maurizio Suppo takes a look at the legislative history of the directive in his article, “The Origins of the IVD Directive” (page 20).
With less than eight months left until the December 7 deadline, it is absolutely imperative for IVD companies to continue, or even start, working on becoming compliant with the IVD Directive. If they don’t, they will jeopardize their ability to do business in Europe.
Richard Park
Copyright ©2003 IVD Technology
