Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The Demarcation of Medical Devices and Medicinal Products in the European Union ***

Dr. Katrin Sauerland (Abschlußjahr: 2001)

Medical devices and medicinal products are products intended to be administered to human beings within a medical context. Different legislative pathways apply related to the product category: Medicinal products are subject to approval by the competent authorities, while the procedural way foreseen to medical devices is based on the more flexible "New Approach" concept of the European Commission, delegating supervision functions to designated institutes, the Notified Bodies.

The demarcation between medical devices and medicinal products is done by definition and exclusion given in the European Directive 93/42/EEC:

Medical devices are not acting via pharmacological, immunological or metabolic
means Directive 93/42/EEC shall not apply to medicinal products

The definition of a medicinal product was therefore not changed when introducing the new legislation of medical devices in the 1990s. Annex I and II of this review contain a comparison of the legal definitions for medical devices respective medicinal products used in the EU, in Germany, in the US and globally.

The following aspects with regard to actual demarcation problems were examined, and possible solutions discussed.

Historical and legal aspects
Borderline products
Combination products
National versus European legislation
Special products
Historical and Legal Aspects
Concerning the actual, legally unsatisfactory situation of exempted products from the application of Directive 93/42/EEC via guideline, the need for a uniform European solution was strengthened. This could easily be done by moving the texts from the guideline directly into the legal texts.

Borderline Products
A rearrangement of the definitions of medical devices and medicinal products was proposed, in order to ensure a clear demarcation concept and transparent law. The installation of a European authority for medical devices was discussed, providing for an individual binding decision for products of borderline status.

Combination Products
As some products are composed of both features, medical devices and medicinal products, Directive 93/42/EEC defines, that applicators for medicinal products are medical devices; but if they form one integral product for single use only in the given combination, then the product as a whole is a medicinal product. If on the other hand, a medicinal product is only of ancillary action to a medical device this product is called a medical device. A concept was designed to avoid cumulative application of both directives.

National versus European Legislation
As European directives need transpositions into the national laws of the Member States, the current status in Germany was examined. Concerning medical devices the European definition was quasi directly copied into the German law, the MPG, while the definition of a medicinal product is varying in details between the Member States. As it is only for the reason of public health to introduce more stringent or additional rules in the Member States, the term risk to public health should be based on a harmonised definition, to avoid misuse of this exception.

Special Products
For the regulation of special products, some initiatives are on the way, for example for the inclusion of medical devices containing human blood or tissues. Products for the use in animals could also be included in Directive 93/42/EEC by amending the definition.

Pages: 39