MDR Article 13(c)

[Hiro＠162]

Helli,

Regarding MDR Article 13(c), the importer shall is supposed to verify that the IFU is attached.

Our products are tamper-proof, and the IFU is included in the box.
Each time the importer checks the IFU, a destructive inspection is required.

Please advise us if there is a good way to fulfill the obligation of the importer to comply with MDR Article 13(c) without destructive inspection.

 

[florijanl]

IFU-s could also be in electronic form. In that case, there is no need for checking I suppose.

 

[krm29]

Perhaps add a checklist with every box which states what inside (device, manual, accessories, etc.). The importer then has an incoming inspection procedure which states that they have verify the completeness of the checklist (and of course sign a form that confirms they have checked completeness of the checklist).

You will probably need a procedure at the packaging site which describes how you are going to make sure that everything on the checklist is indeed in the box before sealing it.

 

[Hiro＠162]

Perhaps add a checklist with every box which states what inside (device, manual, accessories, etc.). The importer then has an incoming inspection procedure which states that they have verify the completeness of the checklist (and of course sign a form that confirms they have checked completeness of the checklist).

You will probably need a procedure at the packaging site which describes how you are going to make sure that everything on the checklist is indeed in the box before sealing it.

Thank you for your comments.

Regarding the checklist, you explain that our company (manufacturer) needs to prove that IFU is enclosed in the product box through process and shipping inspections.
And the importer will use it as a basis for the IFU to be enclosed in the product box.

Is this understanding correct?

 

[krm29]

Thank you for your comments.

Regarding the checklist, you explain that our company (manufacturer) needs to prove that IFU is enclosed in the product box through process and shipping inspections.
And the importer will use it as a basis for the IFU to be enclosed in the product box.

Is this understanding correct?

Yes, basically. Mind you, we have not done exactly this ourselves and were the manufacturer. But we did something related. Our systems supplier delivered the final product to us and we just inspected the signed paperwork included by them. These included not only contents of the box but also specific sub-assemblies that were vital to the safety and performance of the device. This way we could trace these vital sub-assemblies all the way back to the sub-suppliers of our systems supplier without opening anything. The notified body (Dekra) was more than happy with it. But... if any date or signature was found missing during audits, there was hell to pay (rightly so of course).

 

[Mark Meer]

IFU-s could also be in electronic form. In that case, there is no need for checking I suppose.

Careful with this. There are restrictions.
COMMISSION REGULATION (EU) No 207/2012 states eLabelling is only permitted if:

• Only if sold exclusively for use by professionals, and use by other persons is not reasonably foreseeable

And only for the following types of devices:

• Implantables / Active Implantables
• Fixed installed devices
• Devices with a built-in system for displaying instructions
• Stand-alone software

See this thread for a discussion on this topic.

 

[Hiro＠162]

Thank you for your comments about eIFU.
Our product is not approved eLFU, so we have to insert the paper IFU in the product box.