EU MDR GSPR 11.1 (c)
- Thread starter Leona
- Start date
EmiliaBedelia
Quite Involved in Discussions
For a sterile product, I would list (at minimum):
- packaging validation
- sterilization validation
- manufacturing process/cleanroom controls and validations
- references to the risk files where "reduce risk as far as possible" is demonstrated
- reference to IFU/labeling for symbology/warnings regarding contamination and handling
- design validation/usability/human factors supporting point (b)
- any supporting information for point (a) if that is applicable to your device (might be n/a if your device doesn't involve sharps)
If you have anything listed as an RCM for any risks related to this GSPR, you should list them as evidence.
- packaging validation
- sterilization validation
- manufacturing process/cleanroom controls and validations
- references to the risk files where "reduce risk as far as possible" is demonstrated
- reference to IFU/labeling for symbology/warnings regarding contamination and handling
- design validation/usability/human factors supporting point (b)
- any supporting information for point (a) if that is applicable to your device (might be n/a if your device doesn't involve sharps)
If you have anything listed as an RCM for any risks related to this GSPR, you should list them as evidence.
Thank you for your answer
One more question. What about 11.3? Is it relevant for product delivered sterile?
Thank you
Leona
EmiliaBedelia
Quite Involved in Discussions
No. I have previously been told by my NB that "sterile" does not count as a "defined microbial condition" so that should not be applicable.Thank you for your answer
One more question. What about 11.3? Is it relevant for product delivered sterile?
Thank you
Leona
Great, thank you very much
