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Control of medical device IFU content

funkgirl

Involved In Discussions
#1
Looking for some streamlined best practices for managing IFU content... We're also a very small (100 staff) company still working with a paper-based QMS and have 2 different IFUs for each of our 2 global product lines - 1 for the Americas (EN, ES, FR, BP) and 1 for EU (all languages). As we previously only sold into the US and EU, we have historically included all label and IFU requirements (CE Mark, EC Rep, branding, etc.) as design inputs.

I've recently received approval for one of the product lines in Brazil, which requires that we add the license #, distributor name/address, registration holder name/address to the label and IFU. I would prefer NOT to muck with design inputs, do a design review, blah blah blah. The currently approved content is not changing at all, so I don't see the value in adding the registration info to the DHF. If I were changing any text regarding the device or use thereof, that's a different story and would of course put it through design controls. However, this is making my team uncomfortable since we have previously included the CE mark and EC Rep as design inputs.

There's got to be an easier way to do this. While we don't have the bandwidth to make major changes to our process at this point, we do have a Commercial Release procedure that addresses additions to the currently approved labeling in order to ship the product. I'd like to take advantage of this, in addition to Change Control, for release to countries with these type of label requirements (e.g. Brazil) without having to revisit the DHF.

What criteria could I put in place to determine labeling content that must be included in design inputs versus content that can be added through Commercial Release/Change Control?

Thoughts, suggestions, and examples are greatly appreciated!

Thanks,

Tina
 

yodon

Staff member
Super Moderator
#2
I don't know if this will help now, but I generally abstract the design inputs to something like "labeling shall be compliant with all specific country requirements where the device is distributed" and then have a labeling specification for specifics. That way you don't have to change the requirements when you branch into another country but the labeling spec change would be a design change that would need to be controlled (and possibly some blah, blah, blah stuff).
 
#3
Use the CC to add the labeling requirements to the IFUs and do as yodon suggests. Just out of curiosity, do you use a CCMS/ CMS to handle your IFUs (and labeling), how do you produce IFUs?
 
#4
One additional caution besides the above advise: when changing/adding information to a label on a sterile device pack, assess whether your sterilization validation would still be valid. If you have such a case but avoid the relevant parts of the design/development process, you might find your patients or yourself in trouble later.
 
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