Re-labelling in IVDD - Re-label two products and package them as one

#1
Hi
My company is thinking of building a IVDD reagents combining two products from other company.
Our idea is re-label two products and package them as one with our brand and label.
My question is can we use two products stability data in our re-labelled product?
If so what do need to cover the regulatory basis?

Thank you.
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration
Staff member
Admin
#3
Yes - Hopefully someone with medical device experience will help out, but as it goes in forums, sometimes no one spots it. Please understand people who do help out here do so without compensation so there are no guarantees.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
I'm not really from the IVD world (more non-IVD MD) but I'll try to help anyway.
Clarification questions:
- Do you intend to keep the two products from the other company packaged separately, or mix them and sell as a single substance?
- If keeping packaged separately, are you going to relabel the individual products, or to keep the original labelling and just package together in/under/with your own labelling?
Do you have access to the original stability data, or are you planning to test these products to generate your own data?
Regulatory basis - have you considered the IVDR?
R.
 
Last edited:
#5
Thank you for the reply Ronen.
We have not considered IVDR yet.
There is no mixing involved. Just two different components used in one process.
Originally, we were thinking of re-labelling each component and put in one box, but from the question your asking there looks like a difference in regulatory perspective.
We do have stability data for one component but not for the other, so we are thinking of generating our own data.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Given the no-mixing and re-labeling you will most likely need stability data for each.

If you're located in the EU or are planning to sell in the EU, you should look into the IVDR. That will give you detailed, more complete and authoritative answers.
 
Thread starter Similar threads Forum Replies Date
M IVDD ER 8.3 Vs. Hazard Labelling Regulations - Which outranks? EU Medical Device Regulations 2
S Article 22 Procedure Pack Labelling EU Medical Device Regulations 4
F Labelling requirements for a medical device containing fragrance allergens EU Medical Device Regulations 3
S Industry Labelling Standards - non medical Manufacturing and Related Processes 0
JoshuaFroud Serial numbers and labelling when sharing device components ISO 13485:2016 - Medical Device Quality Management Systems 1
TechnicalGuy Colour of symbols on Medical Device labelling and packaging Other Medical Device Related Standards 1
B Practical ideas for information labelling in healthcare environment IEC 27001 - Information Security Management Systems (ISMS) 2
G FDA UDI markings "label" vs. "labelling" (labeling)? US Food and Drug Administration (FDA) 4
R US FDA Mandatory Labelling contents for an OTC medical device US Food and Drug Administration (FDA) 0
M Technical File (STED) labelling - When you compile tech files do we have to include all the product labels? EU Medical Device Regulations 2
M Over-labelling - Any requirements or best-practices? Other Medical Device Regulations World-Wide 0
TheMightyWife Address Change - Medical Device Packaging Labelling Requirements EU Medical Device Regulations 7
S Labelling in Medical Device Software IEC 62304 - Medical Device Software Life Cycle Processes 8
M Is "Made in (Country)" a labelling requirement? Other Medical Device Regulations World-Wide 8
N Own brand labelling/virtual manufacture of IVD's EU Medical Device Regulations 2
M EN 374-2 One time test and labelling Other Medical Device Related Standards 0
V Software medical device labelling EU Medical Device Regulations 5
JoCam UDI - Direct Labelling EU Medical Device Regulations 9
JoCam Medical Device Final Assembly Labelling EU Medical Device Regulations 2
J Malaysia - Full Labelling Local Language Translation Other Medical Device Regulations World-Wide 1
S Adding claims on medical device labelling 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Labelling Requirements for USB-Powered Device Other Medical Device Related Standards 1
JoCam Over-labelling the manufacturers name at the front of the device EU Medical Device Regulations 31
J0anne Alternatives to 'Latex Free' Labelling Other Medical Device Related Standards 9
P CE Marked IVD Labelling Canada - Conformity symbol? Canada Medical Device Regulations 6
B Own Brand Labelling and Distributors - Self Test IVD's EU Medical Device Regulations 3
M Fabric Composition Labelling required for Medical Devices? Other US Medical Device Regulations 1
M Labelling and the harmonized EN ISO 14971:2012 ISO 14971 - Medical Device Risk Management 9
S Is Energy Labelling Directive appliable to the Medical Devices? CE Marking (Conformité Européene) / CB Scheme 2
J Packaging and Labelling Regulatory Reporting EU Medical Device Regulations 12
P OBL (Own Brand Labelling) - Technical Files/Risk Management ISO 13485:2016 - Medical Device Quality Management Systems 3
F FDA Device Labelling/Packaging Information Requirements Other US Medical Device Regulations 3
L Do we need a Labelling SOP for ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 5
E Labelling for 510K submission for a Class II medical device - suture passer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
K Labelling Requirements for Class 1 Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
R Regulation/Standard for Labelling in the UK - Medical Device Directions for Use ISO 13485:2016 - Medical Device Quality Management Systems 7
N What needs to be on the label? Medical Device Labelling Requirements EU Medical Device Regulations 12
U Issue with Labelling of Outer Container - help needed for clarification EU Medical Device Regulations 3
L Identification, Labelling, Maintenence and Calibration Procedures wanted Document Control Systems, Procedures, Forms and Templates 1
R Labelling Requirements - Bare minimum Class I Medical Device Instrumentation EU Medical Device Regulations 5
D Labelling of Medical Devices with DEHP (Di(2-ethylhexyl) phthalate)? Other Medical Device and Orthopedic Related Topics 7
R ISO13485, FDA, MDD 2007, CE Labelling ISO 13485:2016 - Medical Device Quality Management Systems 5
S Medical Device Labelling requirements for Class II software EU Medical Device Regulations 4
Marc Labelling Fruit with Carbon Dioxide Lasers World News 1
chris1price Medical Device Labelling Regulatory Requirements - Barcode Formats ISO 13485:2016 - Medical Device Quality Management Systems 3
M Labelling External Documents - Documents of External Origin Document Control Systems, Procedures, Forms and Templates 15
amjadrana FDA requirement for Minimum Font or Type Size for Labelling 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Ajit Basrur First Public Consultation on Harmonised Classification and Labelling RoHS, REACH, ELV, IMDS and Restricted Substances 0
SteveK Use of Phthalates (PVC) - MDD 2007/47/EC - Has anyone started Labelling Devices EU Medical Device Regulations 71
N Reference to FDA on Label or Labelling - Class II Medical Device US Food and Drug Administration (FDA) 7
Similar threads


















































Top Bottom