The Cove Business Standards Discussion Forums
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

Repacking Medical Devices

Monitor the Elsmar Forum
Courtesy Quick Links


Links Elsmar Cove visitors will find useful in the quest for knowledge and support:

Jennifer Kirley's
Conway Business Services


Howard's
International Quality Services


Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum


Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining


Ajit Basrur
Claritas Consulting, LLC



International Standards Bodies - World Wide Standards Bodies

AIAG - Automotive Industry Action Group

ASQ - American Society for Quality

International Organization for Standardization - ISO Standards and Information

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology


Some Related Topic Tags
medical devices, packaging (general)
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 25th October 2017, 11:29 AM
sbosnl

 
 
Total Posts: 4
Question Repacking Medical Devices

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

Sponsored Links
  Post Number #2  
Old 25th October 2017, 07:05 PM
Ronen E

 
 
Total Posts: 3,736
Re: Repacking Medical Devices

Quote:
In Reply to Parent Post by sbosnl View Post

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
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 by Ronen E; 26th October 2017 at 04:05 AM.
Thanks to Ronen E for your informative Post and/or Attachment!
  Post Number #3  
Old 26th October 2017, 01:32 AM
sbosnl

 
 
Total Posts: 4
Re: Repacking Medical Devices

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!
  Post Number #4  
Old 26th October 2017, 04:00 AM
Ronen E

 
 
Total Posts: 3,736
Re: Repacking Medical Devices

Quote:
In Reply to Parent Post by sbosnl View Post

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!
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?...
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >

Bookmarks



Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Emoticons are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
Medical Device Registration Egypt: Only required for Sterile Medical Devices? 3l5m4r Other Medical Device Regulations World-Wide 9 3rd October 2017 02:53 AM
Repacking of Service Parts and Components for Medical Devices DeGeuk 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1 21st November 2014 07:13 PM
Quality Charges for Repacking Re-Inspected Product gugam Supplier Quality Assurance and other Supplier Issues 3 20th September 2010 05:57 PM
Current Good Mfg. Practice in Manufacturing, Packing, Repacking or Holding Food Polly Pure Bread Food Safety - ISO 22000, HACCP (21 CFR 120) 7 6th December 2009 01:16 AM
Medical Devices QC Testing Procedure - Flexible Medical Solution Bags kbng82 ISO 13485:2016 - Medical Device Quality Management Systems 5 9th November 2006 02:38 AM



The time now is 05:07 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.



Misc. Internal Links


NOTE: This forum uses "Cookies"