Not sure if this has been announced on here yet (it is dated 9th March 2012): the EU have finally introduced a regulation on the use of electronic IFUs
A quick read suggests that it is limited to devices that are only used by professionals and can't be expected to be used by a lay person AND which are:
(a) active implantable medical devices and their accessories covered by Directive 90/385/EEC intended to be used exclusively for the implantation or programming of a defined active implantable medical device;
(b) implantable medical devices and their accessories covered by Directive 93/42/EEC intended to be used exclusively for the implantation of a defined implantable medical device;
(c) fixed installed medical devices covered by Directive 93/42/EEC;
(d) medical devices and their accessories covered by Directives 90/385/EEC and 93/42/EEC fitted with a built-in system visually displaying the instructions for use;
(e) stand-alone software covered by Directive 93/42/EEC.
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:072:0028:0031:EN:PDF
A quick read suggests that it is limited to devices that are only used by professionals and can't be expected to be used by a lay person AND which are:
(a) active implantable medical devices and their accessories covered by Directive 90/385/EEC intended to be used exclusively for the implantation or programming of a defined active implantable medical device;
(b) implantable medical devices and their accessories covered by Directive 93/42/EEC intended to be used exclusively for the implantation of a defined implantable medical device;
(c) fixed installed medical devices covered by Directive 93/42/EEC;
(d) medical devices and their accessories covered by Directives 90/385/EEC and 93/42/EEC fitted with a built-in system visually displaying the instructions for use;
(e) stand-alone software covered by Directive 93/42/EEC.
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:072:0028:0031:EN:PDF
