The link provided is for the EU MDD NB-MED/2.2/Rec4 12.07.2001 draft titled “Software and Medical Devices” Revisions 4.1

This stanards related document is intended to provide guidance to Nofified Bodies and manufacturers on the apllication of all the proviisions which apply to software within the scope of the European Medical Device Directives.

It addresses both classification of software and assessment elements.