1.Manufacturers shall clearly indicate that the instructions for use of the device are supplied in electronic form instead of in paper form.
That information shall be provided on the packaging for each unit or, where appropriate, on the sales packaging. In the case of fixed installed medical devices, that information shall also be provided on the device itself.
2.Manufacturers shall provide information on how to access the instructions for use in electronic form.
That information shall be provided as set out in the second subparagraph of paragraph 1 or, if not practicable, in a paper document supplied with each device.
3.The information on how to access the instructions for use in electronic form shall contain the following:
(a)any information needed to view the instructions for use;
(b)a unique reference, giving direct access, and any other information needed by the user to identify and access the appropriate instructions for use;
(c)relevant manufacturer contact details;
(d)where, how and within which time instructions for use in paper form can be requested and shall be obtained at no additional cost in conformity with Article 5.
4.Where a part of the instructions for use is intended to be provided to the patient, that part shall not be provided in electronic form.
5.The instructions for use in electronic form shall be available entirely as text which may contain symbols and graphics with at least the same information as the instructions for use in paper form. Video or audio files may be offered in addition to the text.