ECDE renewal

Upon the expiration of the five-year ECDE certificate for all hip components, Instrumentaria submitted data on the clinical safety and effectiveness of individual hip components to the notified body SGS UK. By analyzing the results of initiated clinical studies and other post-market surveillance methods, clinical experts from the notified body determined that Instrumentaria’s hip endoprostheses meet the high standards of quality, safety, and effectiveness required by the EU for manufacturers of this type of implant.

Preliminary reports from the ongoing clinical studies clearly demonstrated that this generic design type shows no signs of poor clinical performance. After evaluating clinical safety and effectiveness, the notified body approved the use of the prosthesis for an additional five years by issuing the ECDE certificate. In accordance with relevant regulatory frameworks, the results of the clinical studies will be periodically reviewed to demonstrate the overall effectiveness of the THA system.

Furthermore, by reviewing the necessary and legally defined documentation, the supervisory authority initiated the process of issuing an ECDE certificate for a new femoral component design that will enable our clients to implant components using a minimally invasive approach.