The proposed in vitro diagnostic directive.

After a long delay, the official proposal for the In Vitro Diagnostic (IVD) Directive has been published. Some changes could be made during the process of publishing a final Directive, however, it is unlikely that they will be extensive. Therefore, IVD manufacturers should be aware of the proposed requirements. This article will discuss the scope and conformity assessment procedures of the official proposal and point out some of the major modifications that were made to the preceding draft proposal, which was discussed in a previous article.