Hello,
I am seeking some feedback on a situation.
"Product XYZ is a single use sterile device. XYZ was approved in EU since January 2010 with indication 'ABC' with a paper IFU. In January 2016, for the same product XYZ, we received an expanded indication EU approval with eIFU option to be used with a web leaflet 'DEF'. There is no change to the design of the device between the 2 indications however the labeling is updated with the expanded indication and additional information such as caution/precaution etc. As of January 2016, we already have ABC configuration in the field (hospitals) as well as sitting in our inventory and with the sales force.".
Post January 2016, there will be a point where one would still have units with old indication/paper IFU (ABC) in the field while we have products with new indication/eIFU (DEF). It is not feasible to wait for the stock with old indications to completely deplete (become null) before we can roll out the new indication units.
Questions
- How could we convert the units in the field (hospitals) with old indication & paper IFU (ABC) to new indication with eIFU & a webleaflet (DEF)?
- What steps would you recommend to convert the units in the inventory with old indication & paper IFU (ABC) to new indication with eIFU & leaflet (DEF) (example: rework, etc.)?
- What steps would you recommend to convert the units with the Sales Force with old indication & paper IFU (ABC) to new indication with eIFU & leaflet (DEF)?
- What are the regulatory compliance steps one needs to follow, in order to make this transition for both field/sales force as well as inventory units (example: notify notified bodies, etc.)?
Looking to hear from your experience.
Thank you
Shiven
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[Shiven]
[Regulatory Affairs]
[San Francisco] [CA]
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