Medical Device Procedure Pack IFU's (Instructions for Use)

J1980b

Starting to get Involved
#1
Hi All,

I'm enquiring about the supply of IFU's for Procedure packs.

Assuming a company assembles a procedure pack comprising of individual components manufactured themselves and Medical devices by other Manufacturers and the 'other company' states that their product requires an IFU for its safe use. The Pack manufacturer is required to supply the IFU at the same rate as recommedned by the OEM.

I have seen this in the field, however if there are many components all requiring IFUs there could potentially be a selection of 10-20 IFU's per pack - This I have never seen by any Pack manufacturer.

My question is - How do pack manufacturers get around not supplying IFU's? I'm aware of numerous occasions where a device requires one, but it is not available either in the pack or in the supply carton. Are Pack manufacturers doing thier own risk assessment that is stating that an IFU is not required, irresepective of the OEM information?

Please assume that the Pack is CE marked by its own accord and not assembled in accordance with Article 12.

I look forward to peoples thoughts
 
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Ronen E

Problem Solver
Staff member
Moderator
#3
Hi,

I'd say a non-article-12 device (a pack for the matter) should have its own IFU. How this IFU is created and what its contents are, are up to the manufacturer and the involved NB (if any). Overriding a component manufacturer's instructions may be addressed in the risk management process.

Cheers,
Ronen.
 
V

Vlcekad

#4
Dear collegues,

We plan tu put two CE-marked devices into one box. This will be a system pack. We are base in EU and we plant to market it in EU.

We will be the assembler and manufacturer of one of the devices.
Both devices have primary and secondary package labeles and IFUs.
We will put both IFUs into the box this is no problem.

I am confused how to combine those secondary labels on a single paper box, and what should we display on the box so that it is not confusing.

thanks for advice!
 
M

MIREGMGR

#5
We do something similar. We are the responsible Manufacturer of a device that is sterile-barrier-pouch-packed. Inside the pouch, we also put a second device that we source from another responsible Manufacturer, that in essence is an accessory to our device. The second device is in its own impervious packaging, so our sterilization process does not affect it. Each device has its own regulatory label and CE Mark.

The MDD is less than clear on how to handle this scenario. Our CB has reviewed the situation and is satisfied with our approach, which is that our device's label on the overpack-pouch and on the overall case includes information describing the presence within the overpack-pouch of the second device. The second device's own labeling is present only on that device's own packaging.
 
#6
93/42/EEC 13.1 Instructions for use must be included in the packaging for every device.

By way of exception, no such instructions for use are needed for devices in Class I or IIa if they can be used safely without any such instructions.
 
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