Have you determined your device’s lifetime?

Have you determined your device’s lifetime?

Did you know that there are a total of eleven mentions of a device’s lifetime within the MDR but none of these actually define this new term?

We know it’s not quite life expectancy, it’s not the same as the expiry date, nor is it the duration of use, so ‘lifetime’ is a whole new concept that needs to be determined for each device. Understandably therefore, the assessment of a device’s lifetime has many manufacturers scratching their heads and ruminating on how to correctly determine their device’s lifetime, in a way that doesn’t wrangle with these previously established validations.

We’ve been having the lifetime debate with a few of our clients, who are concerned about getting their documents right and we are guessing that other medical device businesses might also need guidance.

Presuming that you have already read MDCG 2020-8, I’m certain you would not be alone if you had missed footnote 4, which states:

“The expected lifetime is to be defined during the design input phase by considering the current state of the art for a specific intended use and indication of a device”

Whilst this clears up the parameters somewhat, it doesn’t feel terribly helpful for devices that have been in the market for decades and are well past their original design phase. So how should you approach it?

Determining the lifetime of a device should really be a simple exercise that considers both the duration of use of the device and whether it is a single or multiple use scenario.  Then – you should update the PMS and CER accordingly, providing sufficient data to reach a value that complies with the new MDR requirement of expected lifetime.

Of course, every device is unique and there are a variety of options to obtain the desired results, whilst ensuring that they are realistic and, of course, accepted by your notified body. So, if you would like some help defining the lifetime of your particular device and updating your regulatory documents, please get in touch with IMed, so we can discuss the best approach for you.