Device Lifetime and Lifecycle Management

Description: Defining lifetime of a medical device has been an often misunderstood, unclear, and challenging topic for many years and it has become even more critical now that regulatory authorities expect lifetime to be clearly defined and supported by evidence. While disposable devices have often been straight-forward in this respect, implantable, reusable and continuous use devices have proven to be a significant challenge, with lifetimes either not defined or not appropriate to the device or not supported by adequate evidence.
The session will focus on how to properly define the lifetime of different device types considering several approaches such as shelf life, expiration date, implantable life, serviceable life, and usable life. It will also discuss how to handle the “end of life” of a medical device and how this is strictly connected to the overall life cycle management of the product through key quality system processes.
It will provide the point of view of several stakeholders, including the medical devices industry and the EU Notified Bodies.