I want to ensure I'm reading Article 3 correctly;
My reading of this is that any devices not falling into those categories cannot have electronic instructions for use instead of paper. For instance, if we have an active measurement device that is not implantable (e.g., a laser measurement tool), we would always need to provide full paper instructions for use covering point 13 of 93/42/EEC (Yes, we are still under the MDD) unless this device had a built in system for visually displaying instructions.
I am dealing with a non-implantable electronic measurement device for use in surgical theatres, and I am interpreting this to mean that it is not permissible for this device to be provided without paper instructions for use (i.e., we could have an eIFU, but it wouldn't change any of our paper labelling requirements)
Article 3 1.
Subject to the conditions set out in paragraph 2, manufacturers may provide instructions for use in electronic form instead of in paper form where those instructions relate to any of the following devices:
Subject to the conditions set out in paragraph 2, manufacturers may provide instructions for use in electronic form instead of in paper form where those instructions relate to any of the following devices:
- (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.
I am dealing with a non-implantable electronic measurement device for use in surgical theatres, and I am interpreting this to mean that it is not permissible for this device to be provided without paper instructions for use (i.e., we could have an eIFU, but it wouldn't change any of our paper labelling requirements)
....