The document provides general principles for the systematic evaluation of the potential and observed biodegradation of medical devices and for the design and performance of biodegradation studies. The document is not applicable to: a) viable-tissue engineered products; b) methodologies for the generation of degradation products by mechanical processes. Methodologies for the production of this type of degradation product are described in specific product standards, where available; c) leachable components which are not degradation products. Where product standards provide applicable product-specific methodologies for the identification and quantification of degradation products, those standards shall be considered as alternatives.