Change of Sterilization Vendors / Facility

[katastic2908]

Please help,

I was hoping someone could help me because trying to search this stuff on the internet is so confusing and most of the time I just end up here anyway.

We are in the midst of qualifying a new sterilization facility, the one we currently use is closing down the location that we use so we are qualifying one of their other locations.

We are in the process of validating and dose mapping, can anyone tell me if I need to notify the FDA somehow? Also for EU, would this be something I would do on a Significant Change Notification to our NB? TIA

 

[Ronen E]

Hi,

FDA - yes, you will need to have your records updated. How exactly depends on what kind of device it is and what was your initial clearance route.

EU/NB - you are only obliged to proactively notify the NB between audits if the change involves QMS or product-range changes, or the device initially went through the “design examination” route (See MDD Annex II s. 4) in the first place.

Please send me a PM if you’d like to provide detailed information and have me further look into this for you.

Cheers,
Ronen.