Brussels, 3 April 2007 - Eucomed, the European Medical Technology Industry Association, has today launched the second in a series of educational publications on medical technology innovation, focusing on regenerative medicine and human tissue engineering. The objective is to contribute to raising awareness and improving understanding of the nature and value of these products.
Human tissue-engineering and the use of "smart" biomaterials that promote self-repair of damaged tissues offer tremendous promise for improved patient treatment, faster recovery, improved prognosis and a more biologically favourable situation where the body can be stimulated to heal itself. Regenerative medicine products are already beginning to change medical practice today. Human tissue-engineered skin and tissue-engineered cartilage were amongst the first to be used, for the treatment of chronic wounds and burns, and joint degeneration and injury, respectively. Other regenerative techniques are being developed to repair bone, the cornea, the bladder and several other common medical conditions.
Today there are no harmonized rules for the evaluation, authorization and marketing of human tissue engineered products in the European Union. The European Commission's proposal (November 2005) to regulate human tissue engineered products under the new Regulation on Advanced Therapy Medicinal Products is currently being examined by the European Parliament (first reading).
The challenge for the legislator is to ensure that the future regulatory framework is designed in such a way that it allows research and innovation in the field to flourish and the prospect of a timely return on research investment to be realised, whilst at the same time ensuring a high level of patient safety and an equitable access to treatment.
Eucomed represents directly and indirectly 4500 designers, manufacturers and suppliers of medical technology used in the diagnosis, prevention, treatment and amelioration of disease and disability. Small and medium sized companies make up more than 80% of this sector. The European medical technology industry invests some €3,7 billion in R&D and employs near to 445.000 highly skilled workers.
Medical Technology is characterised by a constant flow of innovations, which are achieved by a high level of research and development within the industry, combined with close co-operation with the users. Products have an average lifecycle of only 18 months before an improved product becomes available. In order to maintain high levels of product performance and patient safety, the industry invests heavily in regular user training.
The mission of Eucomed is to improve patient and clinician access to modern, innovative and reliable medical technology.
Mark Grossien
Communications Director
mark.grossien(at)eucomed(dot)be
+32 (0)2.775.92.24
