Article 4
1
Manufacturers of devices referred to in Article 3 that provide instructions for use in electronic form instead of in paper form shall undertake a documented risk assessment which shall cover at least the following elements:
a
knowledge and experience of the intended users in particular regarding the use of the device and user needs;
b
characteristics of the environment in which the device will be used;
c
knowledge and experience of the intended user of the hardware and software needed to display the instructions for use in electronic form;
d
access of the user to the reasonably foreseeable electronic resources needed at the time of use;
e
performance of safeguards to ensure that the electronic data and content are protected from tampering;
f
safety and back-up mechanisms in the event of a hardware or software fault, particularly if the instructions for use in electronic form are integrated within the device;
g
foreseeable medical emergency situations requiring the provision of information in paper form;
h
impact caused by the temporary unavailability of the specific website or of the Internet in general, or of their access in the healthcare facility as well as the safety measures available to cope with such a situation;
i
evaluation of the time period within which the instructions for use shall be provided in paper form at the users request.
2
The risk assessment for the provision of the instructions for use in electronic form shall be updated in view of the experience gained in the post-marketing phase.