Repacking Medical Devices

S

sbosnl

Registered
#1
#1
Hello,

I hope you can help me out..

We are a distributor of medical devices and are repacking some of them;

for example; we receive 3 boxes of 10pcs from 3 different suppliers. for kitting purposes we open all 3 boxes and make 10 kits.

Now the question; should we provide 3 IFU's in the kit and are we seen as manufacturer in this case?
Should we label the primair package with an label according MDR chapter 3, article 23?

The MDR states in article 16.2b that we can repack in order to market the devices as long we inform our customers the actions we took so we don't think we


Thanks in advance!

Stevan
 
GAGEpack - Gage & Calibration Management
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Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#2
#2
sbosnl said:
Hello,

I hope you can help me out..

We are a distributor of medical devices and are repacking some of them;

for example; we receive 3 boxes of 10pcs from 3 different suppliers. for kitting purposes we open all 3 boxes and make 10 kits.

Now the question; should we provide 3 IFU's in the kit and are we seen as manufacturer in this case?
Should we label the primair package with an label according MDR chapter 3, article 23?

The MDR states in article 16.2b that we can repack in order to market the devices as long we inform our customers the actions we took so we don't think we


Thanks in advance!

Stevan
Click to expand...
Hi Stevan,

The EU MDR will apply (most of it) only from 26.5.2020. Currently the applicable requirements are as stated in the MDD 93/42/EEC.

Are the 10-unit boxes you open the retail (end-user) packaging? If yes, you need to follow the MDD and in particular pay attention to Article 12 (assuming these devices are already duly CE-marked). If the 10-unit boxes are essentially shipping/wholesale packaging, you’d just be selling sets of 3 finished medical devices together; however please make sure that you sell them with no changes whatsoever and with any labelling (IFU and other paperwork) that come with each unit. In the latter case it should be very clear from the packaging and labelling of each single device who their (official) Manufacturer is and that it’s not your org.

Cheers,
Ronen.
 
Last edited:
S

sbosnl

Registered
#3
#3
Dear Ronen,

Thank you for answer! As for the later case, we already provide a clear list of articles included in the kit, although we don't mention each manufacturer seperately.. And do we need to include 1 IFU with each item in a unit already, so 10 IFU's in a Box?

Thanks!
 
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#4
#4
sbosnl said:
Dear Ronen,

Thank you for answer! As for the later case, we already provide a clear list of articles included in the kit, although we don't mention each manufacturer seperately.. And do we need to include 1 IFU with each item in a unit already, so 10 IFU's in a Box?

Thanks!
Click to expand...
Please let me see if I understood -

So you take one 10-unit carton of each of the 3 types of devices (shipping / wholesale cartons); you break each carton up to 10 separate units (so you have 10, 10 and 10 devices, all in separate retail packages); you pack them in bundles containing one device of each type (now you have 10 bundles of 3 different devices); and last, you pack 10 bundles of devices into one shipping / wholesale carton. Then each bundle may end up with a different end-user. Correct?

In that situation I would expect each bundle to contain one IFU for each of the different devices - either in/on the original device retail packaging, or added to the bundle (inside the single-bundle packaging you add).

Confused?... :)
 
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