* 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