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EU Regulation 207/2012 - EIFU - Customer Requests

tebusse

Involved In Discussions
#1
Greetings,

I am working to implement our eIFU program in accordance with EU Regulation 207/2012. Currently, our IFUs are offered on our website, but I'm working to set up a program to handle customer requests for printed copies. However, I have a conundrum...

Since our company is extremely small (7 of us), we update our IFUs on at least a quarterly basis due to minor changes in our products. Additionally, the product is built by our contract manufacturer, so we don't do any label/IFU creation on site. As we update the IFU often, it doesn't make sense for us to order them for stock. Instead, we'd rather order one manual from the CM if a customer requests paper. However, this process will be extremely costly. My preference would be for us to print off the IFU in the office and ship it to the customer, but would the process of printing the IFU have to be validated? If so, my thinking is that we could no longer claim exemption to ISO 13485:2016 clause 7.5.6 Validation of Processes for Production.

Please advise.

Tonia
 

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Ronen E

Problem Solver
Staff member
Super Moderator
#2
Validation of processes is required only where the outcomes are not being 100% verified. You can establish a verification process and document that each and every printed manual has been verified (i.e. a qualified person will have to view the manual and confirm that it's identical to the electronic master).
 
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