T
temujin
Dear Forum,
The Medical Device Directive states in e.g. Annex VIII, 3 that:
However, I cannot find any definition, or consensus statement regarding what is a variant, i.e. how much can you change a device before it becomes a completely different system?
Does anyone have any official guidelines regarding this?
regards
t.
The Medical Device Directive states in e.g. Annex VIII, 3 that:
The technical documentation (...) must include in particular:
- a general description of the product, including any variants planned,
However, I cannot find any definition, or consensus statement regarding what is a variant, i.e. how much can you change a device before it becomes a completely different system?
Does anyone have any official guidelines regarding this?
regards
t.