* Implementing labeling requirements to meet MDR requirements, such as:
- Overview of changes
. For implants, quantitative info on materials - how detailed?
. How avoid giving away IP? (Different labels for different regions maybe, and configuration/operational issues with that)
. Listing hazardous substances - how much details? Can we just use the CAS #?
. Clinical benefits - how much detail?
. GSPR 14.7 - disposal - can I just say "dispose of per local hospital requirements?" Yes/No? In what circumstances? What else do I need to do?
. How to refer to the SSCP - is a weblink to Eudamed enough? what if eudamed is not ready and the weblink doesn't work?
. Lay user considerations
. Specify needed user training? Can i just say "users should be board certified interventional cardiologists? When is that sufficient? when is it not? What do i need to do if it's not? Particular requirements regarding Annex XVI devices for implants in this regard per CS
. What warnings/precautions go on the label? how do I decide?
. GSPR 23.1 requirements - website and considerations (cybersecurity, GDPR?, translation, elabeling regulation 207/2012?) How do I decide what S&P info goes on the website?
. Sterile packaging requirements (GSPR 23.3)
. Status of standards and symbols