SBS - The Best Value in QMS software

Repacking Medical Devices

#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
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
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:
#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

Problem Solver
Staff member
Moderator
#4
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?... :)
 
Thread starter Similar threads Forum Replies Date
D Repacking of Service Parts and Components for Medical Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
G Quality Charges for Repacking Re-Inspected Product Supplier Quality Assurance and other Supplier Issues 3
P Current Good Mfg. Practice in Manufacturing, Packing, Repacking or Holding Food Food Safety - ISO 22000, HACCP (21 CFR 120) 7
H Existing cloud based medical device - questions regarding improving the processes IEC 62304 - Medical Device Software Life Cycle Processes 1
L EOL milestone in Medical Devices Regulations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
U EN 455-4 Accelerated Shelf Life tests for Medical Gloves Other Medical Device Related Standards 2
M Does the scope of ISO 9001:2015 applies to tenders, pricing and sales department of a medical devices distributor? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S Statistics and / or Forecasts on medical products exports from China Other Medical Device and Orthopedic Related Topics 1
K Unused Service Parts in Newly Manufactured Medical Device? Other US Medical Device Regulations 1
S Stability sampling for Class 1 medical devices ISO 13485:2016 - Medical Device Quality Management Systems 1
B A.I diagnostic software is considered as medical device in FDA? US Food and Drug Administration (FDA) 5
J Medical device repairs (to upholstery) Manufacturing and Related Processes 4
F Medical cart self certification EU Medical Device Regulations 1
D Clinical Trial for Medical devices in Canada Canada Medical Device Regulations 1
Ed Panek Apple Provides New Medical Device Cautions 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
C Does a medical device active (zinc oxide) needs BPR registration in EU? Other ISO and International Standards and European Regulations 1
DanBOS Cloud Connected Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
dgrainger Informational DRAFT: The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 UK Medical Device Regulations 0
dgrainger Informational DRAFT: The Medical Devices (Northern Ireland Protocol) Regulations 2021 UK Medical Device Regulations 0
M California Board of Pharmacy License for Medical Devices?? Other US Medical Device Regulations 6
P Retention Samples for medical devices ISO 13485:2016 - Medical Device Quality Management Systems 2
K Ground Bond Test for Class I Medical Electrical Equipment - calibration problems IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S Obsolescence of the Medical Device in Various Countries Other Medical Device Related Standards 1
A IT-NETWORK in PEMS Sub-Clause 14.13 for Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
G Medical Device - Borderline/Definition EU Medical Device Regulations 0
S Medical device equipment calibration Qualification and Validation (including 21 CFR Part 11) 1
P European Medical Device Nomenclature (EMDN) and CND EU Medical Device Regulations 3
S Reseller Request to Change UPC on Medical Device via Re-labeling Medical Device and FDA Regulations and Standards News 5
D Hand Held medical device - power supply requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
E Medical device applicability to WEEE Other ISO and International Standards and European Regulations 2
A Medical First Article - Can it be a Delta? ISO 13485:2016 - Medical Device Quality Management Systems 1
J Informal vs formal scope creep... managing non-medical devices through system processes ISO 13485:2016 - Medical Device Quality Management Systems 2
Fjalar Spare parts for discontinued MDD compliant class I medical device EU Medical Device Regulations 4
H Medical Device Label Acceptance Criteria Manufacturing and Related Processes 4
J Calling a medical device a medical device (when it might not be one..) UK Medical Device Regulations 29
B Regulatory Affairs Certification (RAC) Book - Fundamentals of Medical Device Regulations Medical Device and FDA Regulations and Standards News 0
J In-house (NHS) manufacture and use (by staff) of non-medical devices.. any regulations apply? UK Medical Device Regulations 6
N Medical device name in different countries EU Medical Device Regulations 4
dgrainger Informational EC - Medical devices – online manuals replacing paper instructions - Feedback period: 27 April 2021 - 25 May 2021 EU Medical Device Regulations 0
V Medical Device Literature Translation Software ISO 13485:2016 - Medical Device Quality Management Systems 1
R "Medical devices" required in scope ISO 13485:2016 - Medical Device Quality Management Systems 2
R X-RAY Based Diagnostic Veterinary medical Devices Medical Device and FDA Regulations and Standards News 2
Z Over The Air (OTA) updates for medical device Other US Medical Device Regulations 1
H Tukery Medical Device Regulstion Other Medical Device Regulations World-Wide 0
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
A Brexit Mandate for EU Authorised Representative for non medical devices CE Marking (Conformité Européene) / CB Scheme 7
A Canadian Safety Labels for medical electrical equipment Canada Medical Device Regulations 2
A Applicability of Photobiological Safety Evaluation for LED used in medical devices Reliability Analysis - Predictions, Testing and Standards 2
M Medical device certificate in Australia - ARTG certificate Other Medical Device Regulations World-Wide 0
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4

Similar threads

Top Bottom