Team-NB has released a document to clarify the concept of “medical device lifetime”. The Medical Devices Regulation (MDR) does not specifically provide a definition for the medical device lifetime.
Team-NB’s position paper bases its approach on existing guidances and standards to assess the setting of the lifetime of medical devices. As such, it first provides a consideration of different device types and the criteria upon which they can establish their lifetime, of which we can mention the following:
- Active devices
- Software devices
- Implantable devices
- Biological devices
Team-NB provides the following recommendations:
- Manufacturers should define their medical devices’ lifetime considering safe and effective use throughout the useful life, for the device’s entire lifecycle, and following the MDR and existing guidances.
- Unlimited or undefined lifetime should not be claimed, as lifetime must be defined in quantitative terms (number of years, number of uses, etc).
- Manufacturers should identify which elements of the total device lifetime have been verified, considering single-fault safety and reasonably foreseeable misuse, especially for legacy devices.
- Clinical data sources should be used as supportive evidence of the lifetime of the device. If no clinical data is available other sources of data should be taken into account (information for safety, functional use, impact benefit/risk ratio, etc).
- Manufacturers can provide justifications for the lifetime of their devices. Still, they should be related to reasonable risks and the likelihood of failure modes for the device and SOTA, taking into consideration the overall safety and duration of the device.
You can find this and other relevant Team-NB documents in our Position Papers section.