Hope that we can have some further discussion and/or alignment still as a follow-up in this topic.
The GSPR 23.1 (d) states that "By way of exception, instructions for use shall not be required for Class I and Class IIa devices if such devices can be used safely without any such instructions and unless otherwise provided for elsewhere in this Section."
I am of the opinion that this and 23.4(z) are contradictory.
Especially for 'simple' class I devices with a very straightforward use (e.g., electrode wire), it seem ridiculous to me to include an IfU just for such a notice, let alone to include the definitions of serious incident. It may actually confuse users. And in case such a device is solely used together with a device of higher risk class, clearly that higher class device will include a more elaborate IfU where the notice can be included.
I appreciate any input from a forum member here . . . and would like to learn how other manufacturers deal with this.
Since I have not seen an example, nor any guidance, hereby up for discussion my proposal:
"If, in relation to the use of [this product], a death or a serious deterioration of health has occurred, this should be reported to the manufacturer and the competent authority of your country. When in doubt, please consult with a (senior) advisor on regulatory affairs."
