HIMA Labeling Survey: Data is being summarized and will be discussed at the October 29 task force meeting in Washington.

IVD Directive: It is currently expected that the European Council will reach a common position on the Directive by the first quarter of '98 with adoption by the member states to occur by year end '98. The first CE marking would be expected by mid year 2000.

Some changes being included are the addition of more products under Annex 2 List A and List B.; requirements for the notified body to provide a certificate for the design dossier for those products that require full QA modules; technical specifications wi th performance criteria and the possibility that notified bodies will need to perform batch release assessments.

For the essential requirement of "user information", translation into local languages remains highly probable. There are a few countries who currently have product instructions in English and may continue to allow for professional use products only. Self testing products used by the non-professional will be required in the local languages.

>Symbols created by ISO work groups have not yet been approved by the European Standards group. It was indicated at a recent IVDD conference that the approval/ "harmonization" of the symbols should follow the same timeline as the Directive. Acceptance o f these symbols on US labels is still an open issue.

European conferences on Medical Device Directive and the IVD Directive continue to encourage manufacturers to take the Directives and the anticipated changes seriously!