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Commission Regulation (EU) No. 207/2012 E-IFU Applicability

Enternationalist

Involved In Discussions
#1
I want to ensure I'm reading Article 3 correctly;

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:
  • (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.
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)
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
I share your view.
‘fixed installed medical devices’ means devices and their accessories which are intended to be installed, fastened or otherwise secured at a specific location in a healthcare facility so that they cannot be moved from this location or detached without using tools or apparatus, and which are not specifically intended to be used within a mobile healthcare facility
Is yours...?
 

twanmul

Involved In Discussions
#3
I thought so too in terms of this Regulation, however MEDDEV 2.14/3rev1 for "Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD) Medical Devices" seems to indicate that you can also have e-IFU's for IVD's with an intended use for professional users as long as you "provide a 'free of charge’ contact number that can be used in order to have the IFU faxed, mailed or emailed to the user."
 

SKM.Sunil

Involved In Discussions
#4
I thought so too in terms of this Regulation, however MEDDEV 2.14/3rev1 for "Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD) Medical Devices" seems to indicate that you can also have e-IFU's for IVD's with an intended use for professional users as long as you "provide a 'free of charge’ contact number that can be used in order to have the IFU faxed, mailed or emailed to the user."
Why not a QR code or link to get the eIFU, rather providing a contact number.
If the number is an ISD then :nono:....

Even guideline in EUMDR and EUDAMED highlighted to have a virtual link on label/box, where user can get "user information" like IFU and SSCP.
I think it can resolve the primary question itself.
 
#5
Why not a QR code or link to get the eIFU, rather providing a contact number.
If the number is an ISD then :nono:....

Even guideline in EUMDR and EUDAMED highlighted to have a virtual link on label/box, where user can get "user information" like IFU and SSCP.
I think it can resolve the primary question itself.
So, can we do a QR code for eIFU for professional users, even if it says 'contact number'?
 

twanmul

Involved In Discussions
#6
The guidance says contact number but we do use the eIFU symbol on our product labels which contains a URL. I'm not sure whether a QR code could be confused with a UDI carrier going forward, so would seek consultation on that before going ahead with a QR code.
 
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