Tissue engineering and Eucomed news in brief

This study emphasizes the importance of multicellular cultures in providing appropriate signals for vascular organization of skeletal tissues. Eucomed, the European Medical Technology Industry Association, represents directly and indirectly more than 3,500 business entities in Europe and beyond. The Eucomed mission is to create and maintain a suitable framework by enabling the manufacturers of medical technology and other related economic actors to operate, innovate, and market in an open and competitive marketplace, with the ultimate objective to improve the access of patients and clinicians to modern and reliable medical technology products. The paper shows a recent example of the role of Eucomed on the tissue engineering industry as illustrated in its response to the proposal of a regulation launched by the European Commission on 4 May 2005. The proposal covers human-tissue-engineered products, bringing them under the scope of medicinal products. Eucomed's position is that since human-tissue-engineering products are not medicinal products, they cannot be regulated by the existing, unchanged rules for medicinal products. Existing requirements for clinical investigation and for good manufacturing practices for medicinal products should be appropriately adapted from the technical point of view, while maintaining their general ethical requirements. Eucomed has also put forward suggestions to address the specificity of combination products, in particular hybrid products made of human-tissue-engineered products and medical devices.