INDUSTRY NEWS

Survey shows companies still behind on IVD Directive compliance

Richard Park

Are you concerned that your product(s) might not be CE marked by December 7, 2003?

The results of a recent survey indicate that while many IVD manufacturers have taken some action toward becoming compliant with the IVD Directive, a substantial majority of these companies still have a long way to go.

As reported in IVD Technology ("Translation and the IVD Directive," September 2002), a Web site run by Foreign Exchange Translations Inc. (Boston) has been investigating the current state of IVD companies' efforts toward becoming compliant with the IVD Directive by conducting a quarterly survey that focuses on translation issues. This survey intends to provide timely information and analysis to IVD manufacturers that are seeking a CE mark for their products.

Have you contracted with a notified body to work with on CE marking your product(s)?

In the most recent survey, conducted during the third quarter of this year, 78% of respondents said that they had been told by a European purchasing organization that additional products, even if they are currently in the supply chain, will not be purchased after December 7, 2003, if they are not CE marked.

Have you been told by any European purchasing organizations that if you have a product already in the supply chain, after December 7, 2003, it can't be purchased if it doesn't have a CE mark?

At the same time, 63% of the respondents indicated that they were concerned or very concerned about meeting the December 7, 2003, deadline (see figures presented here). This finding confirms earlier warnings, and points to difficult times ahead for many IVD manufacturers.

Have you selected an authorized representative?

The areas of concern for respondents who stated that they were concerned or very concerned about meeting the deadline generally fell into the following categories: challenges with regulatory processes, translation, planning, and resources.

For more information about the survey, visit http://www.ivd-translation.com.

Copyright ©2002 IVD Technology