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MDR - Information in the instructions for use - clause 23.4.(z)

lacri

Registered
#1
Someone can clarify me the point below:
23.4 (z) a notice to the user and/or patient that any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Not sure what's to clarify in that... can you please be more specific?

That kind of notice should be included in the IFU.
(A little silly IMO, because users/patients wouldn't necessarily know what constitutes or doesn't constitute a "serious incident", and wouldn't necessarily know who the relevant "competent authority" is, or how to find out, or what a competent authority is anyway.)
 

twanmul

Involved In Discussions
#3
I think it's fairly clear - we'll probably have to define a serious incident within the IFU and also provide a link to an appropriate vigilance reporting system for the member state (e.g. yellow card reporting in the UK). If you provide devices to customers in different member states, then it may be worth including all of these on your IFU (or different IFU's for different member states).
 
#4
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."
 

Billy Milly

Starting to get Involved
#5
You shall have the IFU prepared and on file (readily available if anyone asks for it). Decision to (not) include the IFU with the device depends on the risk analysis - what is the risk, severity and occurence, if the IFU (with all included details) is not available to the user with each device? So, take the "risk" perspective.
If you conclude that IFU is not necessary (procedure-wise), but you still have to lower the occurence of "not reporting", you can take a different approach - warning on the label, box, packaging, leaflet, etc.
Your proposal seems OK. Following the regulation, you could change the last sentence to When in doubt, report.
 
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