The tricky business of drug/device classification in the EU
E. Gielen en B. Essink, The tricky business of drug/device classification in the EU.
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Introduction
On 3 October, the Court of Justice of the EU published its long-awaited ruling in the Laboratories Lyocentre case in relation to the classification of medical products1,2. The CJEU ruled that a product can be classified as a medicinal product in one EU member state and as a medical device in another. The case is significant for manufacturers of medical devices and medicinal products although it does not provide further guidance on those products belonging to the “grey area” between medical devices and medicinal products. It confirms previous rulings of the CJEU that products can be classified differently in different member states. The judgment of the CJEU goes against efforts to harmonize regulation of the EU market. Based upon prior judgments with respect to the classification of products, the decision was not a big surprise. Nonetheless, it shows that the EU harmonization procedure is far from finished. In fact, EU regulation of the free circulation of goods has emerged from and been strengthened by the judgments of the CJEU3. However, the process of creating common standards across the EU market with respect to the classification of medical products should now be a priority. In the current legislative climate, the CJEU is notable to play a critical role on this front, and politicians should step in with further regulation from Brussels.
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Concluding remarks
The importance of greater clarity across the single market as to the rules governing the classification of products is obvious, especially in relation to the decision of manufacturers in the development, marketing and potential liability of new products. The CJEU’s decision confirms that member states must make classification decisions on a case-by-case basis. It recognizes that there is incomplete harmonization in the EU and, as such, there is a risk that member states may adopt different views leading to inconsistent positions in each jurisdiction. It is clear that the directives in place cannot provide a satisfying solution, and it is increasingly likely that further legislation will be needed to achieve market harmonization for medical products across the EU. The views expressed in this article are for general informational purposes and guidance only and do not purport to constitute legal or professional advice. All information relates to circumstances prevailing at the date of publication.
Ellen Gielen en Bart Essink
