The CE Mark is becoming an increasingly common sight on products available to customers in the European Union (EU). Perhaps less common is a complete understanding of what the CE Mark signifies. For immunodiagnostic product customers, the CE Mark serves as an assurance that a product meets the requirements of the EU’s In Vitro Diagnostic Directive (IVDD). Two years from now, all in vitro diagnostic products intended for sale in the EU will be required to bear the CE Mark. DPC has been prompt to achieve CE marking for many of its IVD products, including important infectious disease assays, some of which are the first to receive this approval.

EU requires CE Mark
The IVDD was published in the Official Journal of the European Communities in December of 1998, beginning the process leading toward final implementation of the directive on December 7, 2003. Formal implementation commenced on June 7, 2000, and on that date DPC was one of only two companies approved to display the CE Mark on marketed IVD kits. During the transition period, manufacturers may continue to market existing products provided that they comply with national regulatory requirements; and they may enter the market with new or newly CE-marked products by complying with the requirements imposed by the IVDD. Although manufacturers are allowed to offer IVD products without CE marking until December 7, 2003, there is already a strong customer preference for CE-marked products if available. This is primarily due to the fact that never before has there been a pan-European IVD “approval stamp” like the CE Mark. All other things being equal, if a consumer can choose between a product with or without the CE Mark, the choice is very clear.

DPC quick to comply
Accordingly, DPC has taken a proactive and aggressive stance toward compliance with the IVDD. The EU member states had until December 7, 1999 to transpose the IVD Directive into their own legislative frameworks, although none had done so by that date. Currently, however, eleven of the EU countries have transposed the IVDD into their laws, and most did so without significant changes to the content of the Directive. Most notably, many member nations exercised their right to add a provision that the instructions for use (package inserts) on professional and home-use products be written in their national language. DPC has accommodated several of these countries so that all labeling of DPC products available in the EU is now printed in six European languages, with more to follow in the coming years.

DPC assays first to receive CE Mark
CE-marked DPC kits ready for commercial distribution on the first date allowable by the directive included almost the entire IMMULITE^®, IMMULITE Turbo, IMMULITE^® 2000 and AlaSTAT^® allergy product lines. The only exceptions were the Company’s Annex II (“high-risk”) products, including assays for hepatitis B virus, Toxoplasma, rubella, and cytomegalovirus which required special, separate approvals. When DPC gained approval for these assays on June 20, 2001, it became the first and only company to do so, a testimony to DPC’s commitment to the infectious disease market worldwide. Customers can be confident that these assays meet the rigorous clinical and quality standards imposed by the IVDD.

Each HBV assay lot formally approved
The EU has allowed member nations to appoint local approval bodies, called notified bodies, which have the responsibility of assuring that a company placing product bearing the CE Mark on the market comply with the directive. DPC chose to collaborate with one of the major notified bodies, Lloyd’s Register Quality Assurance (LRQA), which formed an alliance with the Paul Ehrlich Institute (PEI) in Germany, renowned for expertise in infectious diseases. To obtain these approvals, DPC was required not only to demonstrate a strong Quality System, but also to test its products in clinical settings according to the Common Technical Specifications (CTS) that describe minimum functional requirements for safe and effective kits. Several thousand patient samples, spanning a comprehensive array of markers, conditions and interfering substances, were tested at multiple sites in Europe, in studies comparing DPC kits to the CTS as well as to competitors’ assays on the market. Despite this approval—a significant accomplishment by any standard—DPC must nevertheless continue to obtain formal release of each lot of hepatitis assays for the EU market. The independent LRQA/PEI assessment assures product consistency and, in the long run, improves the public health.

By the end of 2003, all manufacturers will be required either to have their kits bear the CE Mark or to remove them from the market altogether. While many competitors will be rushing to gain approvals by that fateful date, DPC will remain focused on its goal: to provide total solutions for the immunodiagnostics market through quality diagnostic systems and an ever-expanding assay menu.