Re: Regulatory Requirements for Distributors
...and for the EC --
The medical devices regulations apply to the legal manufacturer (no direct and explicit requirements for distributors). Any requirements relevant to distributors, will be ones conveyed to them by the legal manufacturer (your company). Specifically, there is no requirement spelled out for any certified QMS. I think, though, ISO 900x is a nice bonus when you evaluate potential distributors. ISO 13485 for distributors is just nonsense, IMO.
Cheers,
Ronen.