Labeling requirements for Servicing and Repairing Medical Devices

B

bobbyv

Hi All,
:bigwave:
I was wondering what the labelling requirements are for servicing medical devices which were manufactured some years ago which may become slightly worn or illegible, or contain information on their labels which has since changed, such as manufacturer's address details for example.

Is it the responsibility of the contract manufacturer that also services/ repairs the old units to change the old labels to current labels with the current manufacturer's address and details?

My understanding is that all labelling on a medical device must be up to date with respect to manufacturers details, not to mention with respect to current regulatory compliance details referenced on labels as well.

Should a copy of the current IFU be provided as well after servicing or repair?

Thank you,

Boobyv
 
Last edited by a moderator:
Ronen E

Ronen E

Problem Solver
Moderator
bobbyv said:
Hi All,
:bigwave:
I was wondering what the labelling requirements are for servicing medical devices which were manufactured some years ago which may become slightly worn or illegible, or contain information on their labels which has since changed, such as manufacturer's address details for example.

Is it the responsibility of the contract manufacturer that also services/ repairs the old units to change the old labels to current labels with the current manufacturer's address and details?

My understanding is that all labelling on a medical device must be up to date with respect to manufacturers details, not to mention with respect to current regulatory compliance details referenced on labels as well.

Should a copy of the current IFU be provided as well after servicing or repair?

Thank you,

Boobyv
Click to expand...

Hi,

It would be beneficial to state the regulatory domains of interest, because applicable requirements may differ. For this post I'm going to assume you referred to the Australian regulations (because your profile location says Australia).

First, as a general rule any regulatory requirements apply to the legal manufacturer (name on label), not to the contractor performing the service. Some obligations may be (explicitly) subcontracted, but the formal responsibility remains with the original legal manufacturer. This is specifically true for labelling.

I am not aware of a requirement to keep labelling (either label or IFU) of units already on the market updated at all times, although it would certainly be a good practice to update them as necessary. The exception would be a field safety corrective action (e.g. issuing corrected IFU etc.).

It's the original manufacturer's responsibility to ensure upfront that labels remain legible over the lifetime of the device, under normal use conditions and foreseeable misuse. It's the owner/user's responsibility to ensure they keep the IFU or a copy thereof accessible and in a usable condition.

Cheers,
Ronen.
 
Y

yodon

Leader
Super Moderator
Just to add on to Ronen's reply, I would suggest that you have a responsibility to the device owner to point out (potential) nonconformities (which an illegible or incorrect label would be). As Ronen rightly noted, they are responsible for disposition but they certainly need to be informed!
 
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