John
Who did you speak to at MDA earlier today? Did they work in Device Technology & Safety (DTS) or European Regulatory Affairs (ERA)? I suspect the correct section to talk to would be ERA as they would have known about Annex ix of the MDD. They would also know about the classify program I mentioned earlier, it came with all of the bright blue EC stuff that they sent out on mass in the mid 90's. Isn't it funny that which section you talk to within MDA (whether it is DTS, ERA or evaluation) determines the type of advice you get.
