Essentially boild down to:
- Harmonization of the standard with ISO 14971 and related changes to definitions and terms
- Changes to the body contact categories - what is considered external, what is considered internal
- Requirements for presenting the life cycle of the medical device
- Explanation of the bioequivalence of medical devices
- Emphasis on in silico and in vitro testing to minimize animal testing
- Assessment/testing of genotoxicity and carcinogenicity in contact with specific tissues or contact times
- Attention and expansion respective material selection and material characterization
- Requirements for authors of the biocompatability documentation
Yes, Table A.1 is no longer - there are now specific tables in the main text.