Masterstudiengang "Drug Regulatory Affairs"


Classification Issues on the Borderline between Medical Devices and Medicinal Products –- Review of the Current Regulatory Discussions and Decisions ***

Dr. Christel Neiteler (Abschlußjahr: 2009)

Language: English

According to the regulations in the EU, a product must be classified either as a medicinal product or as a medical device but never as both. Nevertheless, this thesis discusses identical products or even the same products in different countries having been regulated once under the one regime and once under the other.

In most cases the classification is clear and follows the nature of a substance, its effects on the body, the indications for use and the manner of its marketing. For a few products in a “grey area” on the borderline, the final decisions on the regulatory status are more difficult and have to be taken on a case-by-case basis. The ambiguity does not arise mainly from the fact that legal provisions including the underlying soft laws might not be clear enough or might be lacking at all. The Directives for medical devices and for medicinal products are complementary to each other and define which product falls under which regime. Once it has been ruled that a product is subject of one of the two Directives the steps to marketing are quite clear. There does not exist an overlap between the existing regulations but the provisions for classifying the respective products are not uniformly interpreted. Although the rules are intended to avoid any doubt, the demarcation of medicinal products and medical devices is still subject to intensive debates on EU level as well as to national lawsuits.

The demarcation line between medical devices and medicinal products is drawn by assessing the products principal mode of action. A medicinal product is one that achieves its principal action by pharmacological, immunological or metabolic means whereas a medical device achieves its principle action by e.g. physical or physico-chemical means. This does not exclude that the device might be assisted in its function by pharmacological, immunological or metabolic means. These terms as defined in EU soft law predominantly, the metabolic means apparently pose problems among the experts with regard to a proper and at the same time uniform interpretation.

Examples for these difficulties are the current disputes with regard to the regulatory status of products containing substances like simeticone and macrogol as well as of products containing viable micro-organism, namely lactobacillus. In addition, particular attention must be paid to borderline cases between medical devices and herbal medicinal products. In this thesis the aforementioned classification issues are reviewed and discussed in the context of the underlying regulatory provisions for both product categories.

It is revealed that the current regulatory decisions on borderline products are partly not based on an in-depth scientific analysis and do not take all specifics into account. Even if for some products the correct demarcation can turn out to be complicated as shown in this thesis, there is the need to objectively interpret scientific findings in relation to the intended principal mode of action of a product in question. Sufficient and appropriate expertise as well as transparency is a key requisite for doing this.

Pages: 77, Annexes: 10