RESUMO
The importance of a correct demarcation between a Medicinal Product (MP) and a Medical Device (MD) is undisputedly one of the major topics related to the development and launch of a new healthcare product. However, for some products the correct demarcation between MPs and MDs can turn out to be somewhat complicated. This article aims to provide an overview on the existing legislation and its adequate application based on a suitable example at hand. Article 2 (2) of the European Directive 2001/83/EC as amended by Directive 2004/27/EC on the Community code relating to medicinal products for human use stipulates that the respective Medicinal Products Legislation must be applied whenever a product can be covered by both the definitions for MPs and for products regulated by other legal provisions enacted by the European Community, e.g. Cosmetic Products (CPs) or MDs. This basic principle implies that the decision to base the risk-benefit assessment of the product in question on the Medical Device Directive (MDD) would contradict the aforementioned constitutional principle, pursuant to which the stricter of the regulatory procedures theoretically possible is to apply in cases of doubt. In contrast to the approval procedure established for MPs, the MDD requires a Conformity Assessment Procedure to be performed by the manufacturer himself and a "Notified Body". Thus, in the majority of cases the responsibility for the risk assessment of MDs lies solely with the manufacturer and is prior to launch not subject to further scrutiny by regulators. Only in specific cases, i.e. for the Conformity Assessment Procedure of Class III MDs which contain an Active Pharmaceutical Ingredient one of the Member States competent authorities designated in accordance with Directive 65/ 65/EEC has to be involved before taking a decision. It is therefore important that the classification of the product is carried out carefully in full compliance with existing legal provisions, also taking into account the related guidance documents issued by the European Commission. The adequate application of these rules is explained using the example of the antiseptic compound polihexanide, which is used both in approved medicinal products (wound antiseptics) and wound irrigation solutions labelled as medical devices.
