Hi All,
I have a query regarding updates to product literature/IFUs as a results of NB findings, with specific references to ERs or GSPRs, where the product literature has been lacking for many years.
Some background (not attempting to justify any lack of documentation)
1. Products are used by lay users, but prescribed by professionals.
2. Products have been on the market in the same format for > 10 years
3. New products introduced have the same user interface as existing products
4. Post-Market Surveillance has not shown any risks as unacceptable relating to user interface
The original devices were developed prior to any usability engineering process being in place, and so a UEF based on Annex C was developed for the devices.
There are no summative tests on the devices and their interface, including IFU comprehension.
The product IFU (same for all products, old and new) has recently come under scrutiny for missing certain aspects from the ERs and GSPRs, and other product specific standards that have been updated over the last 10 years. (That issue in itself is separate, and being managed).
Some of the updates are around symbology and 15223-1, some are around including the indications for use and intended users in the literature, some are on disposal of the device following use.
What would the normal expectations be for updates to the IFU that haven't been driven by any identified risks with regards to requiring summative testing?
The risk management file has not identified any hazard related use scenarios or unacceptable risk that would necessitate the updates, but at the moment the engineering change process and packaging change process do not have a process for documenting any assessment of changes to literature for usability.
Cheers,
TS.
I have a query regarding updates to product literature/IFUs as a results of NB findings, with specific references to ERs or GSPRs, where the product literature has been lacking for many years.
Some background (not attempting to justify any lack of documentation)
1. Products are used by lay users, but prescribed by professionals.
2. Products have been on the market in the same format for > 10 years
3. New products introduced have the same user interface as existing products
4. Post-Market Surveillance has not shown any risks as unacceptable relating to user interface
The original devices were developed prior to any usability engineering process being in place, and so a UEF based on Annex C was developed for the devices.
There are no summative tests on the devices and their interface, including IFU comprehension.
The product IFU (same for all products, old and new) has recently come under scrutiny for missing certain aspects from the ERs and GSPRs, and other product specific standards that have been updated over the last 10 years. (That issue in itself is separate, and being managed).
Some of the updates are around symbology and 15223-1, some are around including the indications for use and intended users in the literature, some are on disposal of the device following use.
What would the normal expectations be for updates to the IFU that haven't been driven by any identified risks with regards to requiring summative testing?
The risk management file has not identified any hazard related use scenarios or unacceptable risk that would necessitate the updates, but at the moment the engineering change process and packaging change process do not have a process for documenting any assessment of changes to literature for usability.
Cheers,
TS.
Seriously, expectations are likely going to be different between any 2 reviewers.