Regulatory Open Forum

Good morning,

Looking for guidance on device labeling requirements by packaging level as we haven't been able to find much out there.

Many of our devices are packaged in a single sterile-barrier tray that is then placed inside another sterile-barrier tray that this then packaged in a carton. Our question isn't related to the sterile-barrier labeling requirements but rather the labeling requirements as a whole based on the package level.  Due to the small size of the trays and the growing global medical device labeling requirements, we aren't able to fit everything on the tray label closest to the device.  Are we meeting the labeling requirements if we incorporate all content requirements on the carton label only and the UDI with HRI, the sterile barrier symbols and possibly the do not open if package is damaged symbol on the tray labels?

------------------------------
Stacy Novak
VP of Regulatory & Clinical Affairs
Resolve Surgical Technologies
------------------------------

As with many Forum topics, this will ultimately depend on the jurisdiction. And we would need further details about the device type.  But in general, yes, we can meet the labeling requirements taking an approach whereby label content is on a secondary package rather than the primary package (notwithstanding particular requirements, if any, for label content on the sterile barrier).

For example, regarding Europe's medical device requirements, 'label' means the written, printed or graphic information appearing either on the device itself, or on the packaging of each unit or on the packaging of multiple devices. Moreover, Annex I.23.1 allows that the location of the label shall be appropriate to the particular device and its intended purpose among other things. And then it reiterates that if this is not practicable or appropriate, some or all of the information may appear on the packaging for each unit.  Yet it nonetheless prescribes a minimum of information for the sterile packaging (see Annex I.23.3).

Also for Europe, the UDI shall be on the label of the device or on its packaging.

Ultimately, be sure your risk analysis supports the ultimate configuration/arrangement you choose.

Good morning,

Looking for guidance on device labeling requirements by packaging level as we haven't been able to find much out there.

Many of our devices are packaged in a single sterile-barrier tray that is then placed inside another sterile-barrier tray that this then packaged in a carton. Our question isn't related to the sterile-barrier labeling requirements but rather the labeling requirements as a whole based on the package level.  Due to the small size of the trays and the growing global medical device labeling requirements, we aren't able to fit everything on the tray label closest to the device.  Are we meeting the labeling requirements if we incorporate all content requirements on the carton label only and the UDI with HRI, the sterile barrier symbols and possibly the do not open if package is damaged symbol on the tray labels?

------------------------------
Stacy Novak
VP of Regulatory & Clinical Affairs
Resolve Surgical Technologies
------------------------------

Hello Stacy,

To add what has already been said by Kevin - and completely agree whichever approach is taken - make sure this is documented in the technical information and risk assessment performed.  Many regulations require information on each level of packaging with the only level not requiring identification, traceability, and information provided to the user is the shipping level.  Depending on the size of the packaging, size of the label, as you already indicated can be worrisome to get everything to fit on one label.  At the direct device level maybe due to limitations on the label only the identification and traceability can be shown.  Then all of the other information to the user is provided at the next level of packaging.  Make it clear in your technical information the levels of packaging, the labelling applied, and information being conveyed to the user.  Then at each packaging level provide the rationale or justification about the content.  Even with symbols this can reduce amount of space, but there are many more symbols now then even 10 years ago.

As with many Forum topics, this will ultimately depend on the jurisdiction. And we would need further details about the device type.  But in general, yes, we can meet the labeling requirements taking an approach whereby label content is on a secondary package rather than the primary package (notwithstanding particular requirements, if any, for label content on the sterile barrier).

For example, regarding Europe's medical device requirements, 'label' means the written, printed or graphic information appearing either on the device itself, or on the packaging of each unit or on the packaging of multiple devices. Moreover, Annex I.23.1 allows that the location of the label shall be appropriate to the particular device and its intended purpose among other things. And then it reiterates that if this is not practicable or appropriate, some or all of the information may appear on the packaging for each unit.  Yet it nonetheless prescribes a minimum of information for the sterile packaging (see Annex I.23.3).

Also for Europe, the UDI shall be on the label of the device or on its packaging.

Ultimately, be sure your risk analysis supports the ultimate configuration/arrangement you choose.

Good morning,

Looking for guidance on device labeling requirements by packaging level as we haven't been able to find much out there.

Many of our devices are packaged in a single sterile-barrier tray that is then placed inside another sterile-barrier tray that this then packaged in a carton. Our question isn't related to the sterile-barrier labeling requirements but rather the labeling requirements as a whole based on the package level.  Due to the small size of the trays and the growing global medical device labeling requirements, we aren't able to fit everything on the tray label closest to the device.  Are we meeting the labeling requirements if we incorporate all content requirements on the carton label only and the UDI with HRI, the sterile barrier symbols and possibly the do not open if package is damaged symbol on the tray labels?

------------------------------
Stacy Novak
VP of Regulatory & Clinical Affairs
Resolve Surgical Technologies
------------------------------

Good morning,

Looking for guidance on device labeling requirements by packaging level as we haven't been able to find much out there.

Many of our devices are packaged in a single sterile-barrier tray that is then placed inside another sterile-barrier tray that this then packaged in a carton. Our question isn't related to the sterile-barrier labeling requirements but rather the labeling requirements as a whole based on the package level.  Due to the small size of the trays and the growing global medical device labeling requirements, we aren't able to fit everything on the tray label closest to the device.  Are we meeting the labeling requirements if we incorporate all content requirements on the carton label only and the UDI with HRI, the sterile barrier symbols and possibly the do not open if package is damaged symbol on the tray labels?

------------------------------
Stacy Novak
VP of Regulatory & Clinical Affairs
Resolve Surgical Technologies
------------------------------