End of Service Lifetime
As a global medical device manufacturer, Ottobock is legally obligated to comply with The European Union Medical Device Regulation of 2017 (EU MDR 2017/745). In order to ensure its products are compliant with EU MDR 2017/745, effective January 1, 2021, Ottobock will adhere to service lifetime standards that are determined by the design and development of its products. Additionally, Ottobock is required to maintain strict Post Market Surveillance for any of its products placed into the market.
A product’s service lifetime is the amount of time that the manufacturer determines the product to be serviceable and for which it can function safely and effectively. Service and maintenance cannot be provided beyond the product’s designated service lifetime.
The EU MDR 2017/745 is in place to help ensure the long-term safety and benefit of those who use prosthetic or custom orthotic products. In order to fully comply with this important regulation, Ottobock is unable to provide maintenance or repair services once a product has reached its specified End of Service (EOS) lifetime. Service life periods vary by product category. Download the EOS Appendix to review the stated Service Lifetime for Ottobock products.
May 2023: Update Notice to MPK Policy
As part of our ongoing commitment to safety, sustainability, and product development, we are updating the service lifetime of select mechatronic knees (MPKs / microprocessor knees).
Effective August 31, 2023, all Ottobock MPKs (C-Leg, Kenevo, Genium, X3) have a Service Lifetime of 6 years.
Please see below for the updated EOS Appendix and/or the product specific statement for Knee Joints (mechatronic).
Please note that Service Lifetimes referenced here apply to the United States and Canada. Local regulations may impact Service Lifetimes in other locations.
EOS Appendix
EOS General Statement from the Manufacturer
If you require a manufacturer’s product-specific statement on its respective Service Lifetime, please download below.