SBS - The best value in QMS software

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
 
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
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?... :)
 
You must log in or register to reply here.
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
B Procedure packs with non-medical devices EU Medical Device Regulations 1
A Medical device labelling Date of manufacture US Food and Drug Administration (FDA) 2
W Non Sterile Medical Device Environmental Tests Other Medical Device Related Standards 4
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
A Clinical assessment sample size - Medical device Class IIb implantable (93/42 directive) EU Medical Device Regulations 2
K 25-year lifetime of medical device - document storage period EU Medical Device Regulations 1
K Relabeling an existing medical device in the field? Other US Medical Device Regulations 6
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
A Reliable sources for following EU medical device regulatory EU Medical Device Regulations 0
T IVDR Medical device software CE Marking (Conformité Européene) / CB Scheme 8
A Customer Approval (Medical Devices) Document Control Systems, Procedures, Forms and Templates 4
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
J Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device Medical Device Related Regulations 0
S Microwave medical waste disinfectant - A medical device or not? Other ISO and International Standards and European Regulations 3
S Registration of Medical Device in Hong Kong - labeling requirements Other Medical Device Regulations World-Wide 0
D Electrical Medical Devices class I EU Medical Device Regulations 0
J Are complaints applicable to development of medical devices? Customer Complaints 2
V Software as medical device (SaMD) replicated for multiple clients through APIs IEC 62304 - Medical Device Software Life Cycle Processes 4
M Is the output of a device a Medical Device? IEC 62304 - Medical Device Software Life Cycle Processes 5
P Do we need to retrospectively use the "MD" symbol (indicating device is a medical device) on labels, e.g. finished devices within expiration date? EU Medical Device Regulations 2
M Do I need separation in my circuit with a medical charger? IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
L Medical device registration in Iran Other Medical Device Regulations World-Wide 0
P ISO 8 classified medical manufacturing room Qualification and Validation (including 21 CFR Part 11) 1
H EU CE marking for Medical Device Class I EU Medical Device Regulations 2
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Brian Benzarti Medical Devices CLP Regulation Quality Assurance and Compliance Software Tools and Solutions 2
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 4
R Compatibility studies - Medicinal Product and Medical Device Other ISO and International Standards and European Regulations 0
K CE Marking Class 1 (Non sterile) medical device CE Marking (Conformité Européene) / CB Scheme 3
J Medical Device Regulations in Lebanon? Other Medical Device Regulations World-Wide 2
dgrainger Informational Medicines and Medical Devices Act 2021 UK Medical Device Regulations 0
J Calibration cycle for monitoring & measuring tools used in medical device manufacturing General Measurement Device and Calibration Topics 5
S Medical Device MRI Compatibility EU Medical Device Regulations 3
M NICE Medical Technology Evaluation Programme - Recommendations Service Industry Specific Topics 0
A ISO 13485 for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7
R Components to a finished medical device, MDR requirements Other US Medical Device Regulations 1
J Warnings/Cautions in Medical Device IFU Medical Device and FDA Regulations and Standards News 4
L Medical device HIPAA compliance in encryption Medical Information Technology, Medical Software and Health Informatics 1
A Sampling plan for in-process QC (medical devices) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 13
M V&V phase: Justification of acceptance criteria (statistical method ) - (Medical Device) Design and Development of Products and Processes 2
E Medical Device - CE marking - Local market notifications EU Medical Device Regulations 2
S Medical Device Registration in Qatar Other Medical Device Regulations World-Wide 1
B Specialized Medical Apparel Manufacturing and Related Processes 1
B Free Sales Certificate for Non Medical Devices Other Medical Device Related Standards 2
M Medical device substance based-leachables Other Medical Device Related Standards 2
K Usability for custom made medical devices IEC 62366 - Medical Device Usability Engineering 5
P Anyone have an Idea on UAE Medical device registeration- Class B with FDA only Other Medical Device Regulations World-Wide 0

Similar threads

Top Bottom