Thank you for the info. Now, coming back to my original question:
Can we use batch release sterilization data (instead of full validation) to obtain CE mark? and if so, does it come with post market stipulations of some sort.
AAMI TIR 16 specifically talks about batch release, but it's not an harmonized standard.
Regards,
Shimon
Devices delivered in a sterile state must have been manufactured and sterilized by an appropriate, validated method.