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
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