The medical devices directive

There will be eventually be three Directives concerning medical devices. The Medical Devices Directive covers most kinds, but active implantable devices (such as cardiac pacemakers and insulin pumps) have their own Directive, and a third Directive to cover In-Vitro Diagnostic Devices (such as pathology laboratory equipment and pregnancy test kits) is still in draft. All three of these directives follow the “New Approach”, i.e. they specify the “Essential Requirements” which products must meet, but only in outline, and technical detail is provided by “harmonised standards”. This paper concentrates on the general Medical Devices Directive but the other two are very similar in content