BSE und Medizinprodukte
Die gesetzlichen Regelungen in der EU und in Deutschland
Dr. Ehrhard Anhalt und Dr. Elmar Kroth
Bundesfachverband der Arzneimittel-Hersteller e.V. - BAH, Bonn
Directive 93/42/EEC on medical devices stipulates requirements, which also refer to the protection against BSE/TSE, particularly in the essential requirements and the conformity assessment procedures. In order to provide more concrete details to Notified Bodies, manufacturers and interested parties the Guidelines on assessment of medical devices incorporating materials of animal origin with respect to viruses and transmissible agents have been elaborated by industry and authority experts and published by the Commission. This document refers to the relevant harmonised standards and opinions of the Scientific Steering Committee e.g. for the safety of gelatine or tallow. However, legally binding are the provisions of each Member State. Thus, the European Commission is preparing a legal act and has published a draft decision concerning medical devices and TSE. European-wide provisions are most useful, not only because medical devices can be put into the market places of all Member States of the EU after the manufacturer has executed only one conformity assessment procedure.
pharmind 2001, Nr. 1, Seite 27