Abstract
In order to guarantee the quality, safety and efficacy of Tissue Engineered Medical Products (TEMPs), the application of risk management strategies by all parties involved in the life cycle of TEMPs is of the utmost importance. Due to the novelty of TEMPs, their risks have not been clearly and completely identified yet. Extrapolation of experiences with related medical products indicates that the most important risks of TEMPs will relate to the transmission of disease, biocompatibility and efficacy. Many of the risk control measures included in current regulations and standards covering related product categories like medicinal products, blood (products) and medical devices are applicable in generic form to TEMPs. From a regulatory perspective control measures for TEMPs should be combined into a regulatory framework that is complementary to and connects with current European regulation on medical products. Decisions on risk acceptability should preferably be based on predefined standards. Development of internationally accepted standards is therefore essential.
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