SBS - The best value in QMS software

Labeling and UDI requirements for medical device kits

C

celticfrosting

Starting to get Involved
#1
#1
Hello, I’m trying to understand the UDI and labeling procedures when building medical device kits and the requirements necessary. I’ve been looking into something called “convenience kits.” The instruments are reusable class I pieces.

The items will be packaged together in a kit, steel carrying tray enclosure. The instruments (not the tray) will be cleaned and sterilized by the end user before use on a patient. The instruments in the kit are not interchangeable and will remain together before and after use. This would not classify as a convenience kit I’m assuming?

Can it still be packaged with a UDI Device Identifier to encompass it as a complete medical device?

Does the package label need to list all the contents inside the kit or can I give it a simple device name?
 
12 questions to ask before buying a QMS
Elsmar Forum Sponsor
S

Sulamistan

Moved On
#2
#2
According to CFR 801, the convenience kit is defined as follows,

Convenience kit means two or more different medical devices packaged together for the convenience of the user.

It would not be classified as a convenience kit if it is replaced, substituted, repackaged, sterilized, or otherwise processed or modified before the devices are used by an end user fulfills these purposes. I guess that rules out your 'kit' as convenience kit.

If it is not a convenience kit then I guess you would need to follow UDI rule for each of the components.

FDA published guidance on convenience kit might help.

Unique Device Identification:Convenience Kits
 
C

celticfrosting

Starting to get Involved
#3
#3
I did get a response from the FDA Help Desk - "There does need to be a DI for the whole assembly of case and instruments because this is a kit (even if not a convenience kit) and kits (collections of medical devices) are, in and of themselves, medical devices."

With that said it can still be packaged together with a single DI to encompass it entirely – it would be a single medical device. Do the instruments inside require separate UDIs on them as well? The instruments are all class I.

If the kit was registered on the GUDID database, and for one particular instance not all the pieces were contained in it or certain items were swapped with different ones - it would not classify as said kit? I would have to make a new kit variant?

Is it possible to create a kit that is always interchangeable regarding the pieces inside, but have the same kit name and UDI when used?
 
R

RL-WANG

Registered
#5
#5
Hi guys! I found a complete guideline for Unique Device Identification system (UDI system) Application Guide from IMDRF group.
Go to IMDRF webpage www imdrf org and look for IMDRF Documents.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
D 820.120 UDI (Unique Device Identification) Labeling Verification Requirements Other US Medical Device Regulations 11
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 1
A UDI and Design Controls - Labeling change via the Design Control process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
P UDI labeling for power module IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
DitchDigger UDI, Labeling Accessories, General Insanity, Etc. US Food and Drug Administration (FDA) 1
G FDA UDI markings "label" vs. "labelling" (labeling)? US Food and Drug Administration (FDA) 4
M UDI labeling MDR requirement for reusable medical device accessories EU Medical Device Regulations 12
K UDI Labeling for Medical Device Samples 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
T UDI Labeling of Convenience Kits 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Q UDI- RFID Labeling Other US Medical Device Regulations 4
K UDI Labeling for Clinical Investigational Device Other US Medical Device Regulations 3
Pmarszal UDI (Unique Device Identification) Transition Period - Packaging Labeling Other US Medical Device Regulations 5
M GUDID/UDI Packaging and Labeling Questions Other US Medical Device Regulations 6
D Hazard symbols and labeling ISO 13485:2016 - Medical Device Quality Management Systems 1
M IEC 62304 Software changes - Minor labeling changes on the GUI IEC 62304 - Medical Device Software Life Cycle Processes 3
D Labeling requirements for reagents, etc ISO 13485:2016 - Medical Device Quality Management Systems 4
Anonymous16-2 Labeling Question (Dietary Supplements/Food) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
L Medical-grade power adapter labeling Other US Medical Device Regulations 2
Y Labeling difference for storage and operating conditions EU Medical Device Regulations 1
H MDD Article 12 Labeling for Class IIa Medical Device - Please Advise EU Medical Device Regulations 3
K China Medical Device Labeling requirements - Language China Medical Device Regulations 3
S Special 510(K) - Labeling change from Rx to OTC Other US Medical Device Regulations 11
N Device Labeling - Medtronic Ventilator Files (Risk Management documents) Coffee Break and Water Cooler Discussions 2
JoCam Labeling to Customer Requirements EU Medical Device Regulations 1
Z Labeling for Medical Device Samples - Surgical instruments 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
D Change Control - Product Name Change and its associated labeling EU Medical Device Regulations 7
D Do User Manuals (Not Device Labeling) HAVE to be in their national languages for these countries? Will English Hardcopy not do? EU Medical Device Regulations 12
S How to decide which medical device symbols go on label and labeling? US Food and Drug Administration (FDA) 4
M MDR Legacy Medical Device Labeling compliance timeline EU Medical Device Regulations 3
M Informational US FDA Draft Guidance – Breast Implants – Certain Labeling Recommendations to Improve Patient Communication Medical Device and FDA Regulations and Standards News 0
M Labeling for off-label use - Prevention of off-label use of a medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Informational US FDA Final Guidance – Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final Guidance – Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings – Labeling Considerations Medical Device and FDA Regulations and Standards News 0
A Labeling - 2017/745 - EUMDR Requirements and Trademark Issues EU Medical Device Regulations 0
K Labeling requirements - Date of manufacture for software devices EU Medical Device Regulations 5
E Annotated US Prescribing Labeling US Food and Drug Administration (FDA) 0
T Product Labeling - Modified the name of one of our products EU Medical Device Regulations 5
M Informational US FDA draft guidance – Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment Medical Device and FDA Regulations and Standards News 0
T Labeling Requirements - Creams in tubes EU Medical Device Regulations 3
K EU MDR Art. 22 - Device + insertion pack - User manual and Labeling EU Medical Device Regulations 4
M MDR 2017/745 sterile and non-sterile labeling EU Medical Device Regulations 12
M Professional Use Medical Software French Labeling for Canada -- Not Considered Medical Device Canada Medical Device Regulations 2
CPhelan Labeling template on QMS - Kitting and labeling documentation Manufacturing and Related Processes 9
G How is the labeling of units cleared for both Rx and OTC uses handled? US Food and Drug Administration (FDA) 4
E FDA Supplier Labeling Requirements ISO 13485:2016 - Medical Device Quality Management Systems 1
L Class IIa Medical Device, CE Mark & 510k - Labeling Content CE Marking (Conformité Européene) / CB Scheme 4
M Scrubbed version of a labeling procedure that is MDR compliant wanted EU Medical Device Regulations 3
T Change to Country of Origin on Medical Device Labeling Other Medical Device Regulations World-Wide 0
L EU-MDR-Annex I - 10.4 (CMR & Endocrine-disrupting properties) - Labeling Content EU Medical Device Regulations 5
I Medical Device Packaging Multilingual Labeling EU Medical Device Regulations 3

Similar threads

Top Bottom