Profile

Welcome Annie!  ------------------------------ Stephanie Christianson, PhD Senior Regulatory Affairs Product Manager Kimberly-Clark United States ------------------------------

Saschka,  There has definitely been some great discussion especially regarding reprocessing/useful life.  Here are a few resources I like to keep handy:  https://compliancenavigator.bsigroup.com/en/medicaldeviceblog/sterilization-of-medical-devices2/  - this also gets into some of the affiliated ...

Anne,  For the UK:  For Devices: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1137842/Device_Registration_Reference_Guide_Feb_2023_Final_v1.pdf For Medicines I find the pre-submission checklist very helpful: https://assets.publishing.service.g ...

The last one I did about 8 months ago only took a little over 7 business days.  ------------------------------ Stephanie Christianson, PhD Senior Regulatory Affairs Product Manager Kimberly-Clark Remote - Durham, NC United States ------------------------------

Usha,  To follow-up on Anne's response. If this is for EU MDR compliance, ensure that you notify your authorized representative (if you have one) as well as your importer (if you have one). Also, you will want to ensure your internal documentation is updated in full with the change in PRRC as this ...