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Europe's IVD Directive:
More work ahead for diagnostic manufacturers
John F. Place
Now that the European Union has published the final text of its IVD Directive (Official Journal of the European Union, December 7, 1998), diagnostic manufacturers at last have a regulatory framework that will eventually apply uniformly in all member states of the EU. Regulatory harmonization is, in fact, the most important achievement of the directive. It will eliminate the costly and burdensome regulations that would otherwise be imposed by individual member states, and will enable manufacturers to sell their products throughout the entire EU with only a single product approval.
Before they begin celebrating too heartily, however, manufacturers should pause to reflect on the amount of work that will be needed for industry to come into compliance with the directive. Even with the directive's one-year waiting period to enable member states to transpose the directive into national legislation, and a further four-year period of application and transition before the directive becomes fully effective, manufacturers may find themselves hard pressed to achieve conformity by the final implementation date of December 7, 2003.
The CTS Dilemma
Unquestionably, manufacturers are highly motivated to achieve compliance with the IVD Directive and to begin using the CE mark on their products at the earliest possible opportunity (that is, on June 7, 2000). Competitive forces and the demands of hospitals and other customers are operating to ensure that manufacturers stay focused on this goal. Nevertheless, industry progress toward compliance is being hindered by the fact that the Article 7 committee that will assist the European Commission in compiling the common technical specifications (CTS) with which all manufacturers are required to comply has not yet held its first meeting.
Assuming optimistically that the CTS could be completed and agreed to within the next 10 months, this would provide industry with a mere six months to comply with the terms of the directive, register products, and obtain the CE mark. Companies that are unable to accomplish these tasks by June 7, 2000, would rapidly find themselves at a competitive disadvantage.
Keeping in mind that it took the European Commission more than three years to draft and agree to the much less technical directive itself, the period left for developing and agreeing to the CTS seems extraordinarily short. To keep implementation of the directive on track, the commission will need to move quickly to start the procedure, and the national competent authorities will need to work together effectively to arrive at a consensus.
A similar hindrance to manufacturer progress is the lack of a uniform classification system for all of the products that will need to be registered under the directive. As currently conceived, the EUDAMED project to create a European regulatory database is unlikely to be ready for registration of all IVD products by June 2000, when CE-marked products can first be placed on the market. Without such a system, implementation of the directive will almost certainly fall off schedule.
A solution to this problem would be for the EUDAMED project to adopt the classification system developed by the European Diagnostic Manufacturers Association (EDMA) and already in use by industry. Industry is proposing a "code-only" classification system that simplifies registration and avoids the problems inherent in language translation. The vast majority of IVD products (except perhaps self-testing products and those specified in Annex II of the directive) could be readily registered using such coded information.
Most important, the EDMA system is already in existence. Adopting the EDMA classification and a code-only registration system immediately would enable member states to make a working registration software package available to industry in short order, and certainly within the 18-month transposition period.
Unresolved Conflicts
In some areas, the IVD Directive poses problems that it does not resolve, and that may prove thorny as manufacturers come closer to implementation. In the matter of languages, for instance, the directive permits the national competent authorities to decide whether national languages must appear on product labeling. Since each of the EU's competent authorities represents and responds to its own national and political pressures, it will probably be difficult to avoid having member-state national language requirements on the labeling of products for professional use.
In practical terms, however, such requirements are likely to prove both expensive and cumbersome for manufacturers. The added costs of label preparation, translation, separate packaging, and so on will make products substantially more expensive—especially if they are multiplied to accommodate all of Europe's smaller language markets. And even if such requirements are imposed, it is doubtful whether the use of products with national languages can be enforced in Europe's single market, with its internal cross-border trading and parallel imports.
Most exasperating, however, is the absence of any evidence that such national language requirements would offer any real benefit to patients or to Europe's healthcare systems. For all these reasons, industry is opposed to the imposition of such unnecessary national language requirements.
Another problem area centers on a difference of views over the level of risk inherent in the IVD products regulated by the directive. Some of these differences may have arisen because some groups in Europe hoped and expected that passage of the IVD Directive would also bring about changes in the practice of laboratory medicine. In this expectation they were disappointed; the directive is intended to regulate only IVD products, not their use.
Looking to traditional pharmaceutical regulation as a model, some potential notified bodies appear to believe that certain IVD products can be dangerous in and of themselves, and that only strict control of such products can avoid dangerous outcomes. The IVD industry, on the other hand, believes that its products are safe and reliable. In this view, the mistakes of the past (such as the release of HIV-tainted blood in France) resulted not from unsafe products, but from poor decisions about health policy, including whether to use available products. Other problems commonly blamed on IVD products often turn out to be due to operator or procedural errors (e.g., transposition errors, failure to use confirmatory tests). In addition, industry points to recent cases in which manufacturers' own vigilance systems have led to product alerts, thus protecting patients from possible harmful products.
Seeking Harmony
As one of Europe's new-approach directives, the IVD Directive represents a departure from traditional regulatory thinking. In place of national regulation, the directive establishes a harmonized regulatory system that will operate across the entire unified market of the EU. In place of strict premarket controls along the lines of pharmaceutical regulations, the directive creates a third-party assessment system balanced with postmarket surveillance by the national competent authorities.
Such a new approach is not without critics. Some European countries (France, for instance) are reluctant to adopt the new approach, and would prefer to maintain a strictly national system of premarket controls administered by government authorities. Recent FDA comments criticizing the European third-party assessment system suggest it is possible that the agency might reverse course, away from harmonization and back toward protectionism and the "pharmaceutical" way of thinking about regulation.
Industry believes otherwise. The IVD Directive will raise the level of regulation for IVD products in Europe and, when applied together with the CTS, will increase the uniformity and quality of higher-risk products. Although the directive may raise barriers that make it more difficult for small companies to enter the market, it will also undoubtedly lead to the disappearance of some products that are well below the high standards of the IVD industry as a whole.
Industry will have a great deal to accomplish in order to bring itself into conformity with the IVD Directive, but the directive still offers a better regulatory model than returning to the pharmaceutical model of strict premarket controls. Those who argue for a return to the old model might do better to consider what real patient benefit might come from better regulation of medical procedures and accreditation of medical facilities. In Europe, decisions about health policy are still very much a national issue. Compared with product regulation, the regulation of medical procedures is weak and not at all harmonized. Critics of the IVD Directive might usefully turn their attention to those issues instead, and allow diagnostic manufacturers to get on with the substantial work already at hand.
John F. Place is director general of the European Diagnostic Manufacturers Association (Brussels) and a member of the IVD Technology editorial advisory board.
