Hi all,
We are currently in the middle of our technical review for one of our Technical Files (our last one to transition!!) and could do with some advice.
The devices in question are non-sterile Class IIb, Rule 9 device. They have a defined lifetime in the form of reprocessing cycles and the equivalent number of years based on the average number of reprocessing cycles the devices undergo per year (200/2 years).
However, we are facing a lot of push back from the reviewer that we should be including an expiry date on the label. It's not something that has come up in any of our previous reviews.
This was our initial answer:
Whilst there is a defined lifetime for the non-sterile devices which is described in the IFU, this is based on the number of reprocessing cycles (200) and the equivalent number of years (2 years) from the first use of the device. Therefore, it is not relevant to include an expiry date on the label since the expiry date is based on the date of manufacture and not the date of first use. Since the devices are non-sterile, they are not packaged in sterile packaging therefore this type of packaging shelf life validation is not required. In addition, they are manufactured from medical grade stainless steels and engineered plastics that are highly unlikely to degrade during storage.
And their next round question:
As the absence of a “use-by“ date constitutes an implicit claim of an infinite shelf life. Kindly inform whether a formal rationale or justification is available to ensure that the product's performance and safety will not deteriorate during over time which may lead to unacceptable risk imposed to the patient. If such information is available, please provide it.
We can write a rationale but it will only be a more detailed version of the initial answer we gave as we do not have anything more and I'm concerned the next round will be still pushing towards putting an expiry date on the label.
Has anyone faced a similar line of questioning or have any advice?
Thank you
We are currently in the middle of our technical review for one of our Technical Files (our last one to transition!!) and could do with some advice.
The devices in question are non-sterile Class IIb, Rule 9 device. They have a defined lifetime in the form of reprocessing cycles and the equivalent number of years based on the average number of reprocessing cycles the devices undergo per year (200/2 years).
However, we are facing a lot of push back from the reviewer that we should be including an expiry date on the label. It's not something that has come up in any of our previous reviews.
This was our initial answer:
Whilst there is a defined lifetime for the non-sterile devices which is described in the IFU, this is based on the number of reprocessing cycles (200) and the equivalent number of years (2 years) from the first use of the device. Therefore, it is not relevant to include an expiry date on the label since the expiry date is based on the date of manufacture and not the date of first use. Since the devices are non-sterile, they are not packaged in sterile packaging therefore this type of packaging shelf life validation is not required. In addition, they are manufactured from medical grade stainless steels and engineered plastics that are highly unlikely to degrade during storage.
And their next round question:
As the absence of a “use-by“ date constitutes an implicit claim of an infinite shelf life. Kindly inform whether a formal rationale or justification is available to ensure that the product's performance and safety will not deteriorate during over time which may lead to unacceptable risk imposed to the patient. If such information is available, please provide it.
We can write a rationale but it will only be a more detailed version of the initial answer we gave as we do not have anything more and I'm concerned the next round will be still pushing towards putting an expiry date on the label.
Has anyone faced a similar line of questioning or have any advice?
Thank you
