Hi All,

After learning about Guidance Documents, I found them to be a very useful tool for getting devices approved in the EU. There are three groups that write guidance documents: MEDDEV Guidance Documents, NB-MED Guidance Documents, and Competent Authority Guidance Documents. I believe each has a use, but that the NB-MED Guidance documents would be the most useful. As they are written by the notified bodies, who can pass or fail a device for sale, they seem to carry the most weight.

As I mentioned above all seem to be very useful, but which do you consider to be most useful for getting a device through the regulation process in the EU?

-Andrew Nashed