Information on stability and lifetime
Within the Medical Device Directives it is stated in Annex I.4 (MDD) and Annex 1.3 (AIMDD) “The characteristics and performances … must not be adversely affected to such a degree that the clinical conditions and safety of the patients … are compromised during the lifetime of the device as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use.” Therefore the CER for an implant needs to include evidence-based information on the stability and lifetime of the implant in a human being.
What does that mean?
Factors influencing stability and/or lifetime of an implant in vivo have to be identified and discussed. For absorbable implants, the stability retention profile, including time to total loss of stability, and the absorption profile, including time to total mass absorption, have to be provided.
For nonabsorbable implants, information with regard to loss of stability over time and implant survival rates after defined time periods is required. The evidence should be based on clinical data. If bench tests and/or preclinical data are used, their transferability to clinical use needs to be critically discussed.