UDI (Unique Device Identification) Transition Period - Packaging Labeling

Pmarszal

Involved In Discussions
#1
Is there any foreseeable issues to label a Package of 5-units package with UDI even though we are shipping 5 individual units not labeled with the UDI barcode (manufactured before Sept. 24th)?

We would like to implement the package labeling right away and was wondering if there is any issues with this?
 
Elsmar Forum Sponsor

QA-Man

Involved In Discussions
#2
I am not exactly sure what you mean but you don't have to label products with a UDI that were manufactured before a UDI deadline.

So if it is class II and doesn't fall into a category with an earlier deadline (like "life-supporting) you don't have to label it with a UDI if it was made before 2016-09-24.
 

Pmarszal

Involved In Discussions
#3
QA-Man! You have been of great help!

I understand that items manufactured prior to the deadline is an exception and we are not re-labeling these parts.

What my question is if it poses any issues if we label the package label with UDI (which we do at the time of shipment) even though the individual parts in that shipment are not labeled with UDI (because the parts were manufactured prior to deadline)?
 

QA-Man

Involved In Discussions
#4
If they're single use and one in a box, no UDI required at all. No problem

If you're not lucky enough for this to be the scenario, I would still say no problem. Many companies have had all sorts of barcodes on all sorts of packaging levels before UDI that look just like UDI's. You're just another company who chose to barcode their product as they saw fit before being required to do it in a particular way.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
I'm also not aware of any reason why you shouldn't do what you plan. Moreover, my interpretation is that you actually should UDI-label the 5-packs even though the individual devices inside are exempt, if packaging of the 5-packs occurs after the Compliance Date. Packaging is a manufacturing step, if the package is a retail one. Even if it's a shipping / wholesale package, it might be seen as a manufacturing step if it's the only shipping packaging layer and done by the original device manufacturer - your company (i.e. not by a distributor etc.).

Added in edit: Shipping cartons are generally exempt from UDI marking, so maybe it's not such a clear cut. It depends on the nature of those 5-packs. Sorry if I misled anyone.
 
Last edited:
Thread starter Similar threads Forum Replies Date
K Is UDI (Unique Device Identifier) symbol mandatory under EU MDR? EU Medical Device Regulations 1
M Informational EU – Unique Device Identification (UDI) System – FAQs Medical Device and FDA Regulations and Standards News 0
S Looking for procedure on UDI (Unique Device Identification) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S UDI (Unique Device Identification) Requirements for Remanufactured devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Edward Reesor UDI (Unique Device Identification): HIBCC or GS1? ISO 13485:2016 - Medical Device Quality Management Systems 31
H UDI (Unique Device Identification) Requirements for IVD Software EU Medical Device Regulations 2
B Class II Medical Device UDI (Unique Device Identification) Question(s) Other US Medical Device Regulations 8
D 820.120 UDI (Unique Device Identification) Labeling Verification Requirements Other US Medical Device Regulations 11
S Understanding UDI (Unique Device Identification) Other US Medical Device Regulations 10
M UDI (Unique Device Identification) for Convenience Kits with several options Other US Medical Device Regulations 3
M UDI (Unique Device Identifier) ISO/IEC 15459 (Unique Identifiers) Requirements Other US Medical Device Regulations 4
J UDI (Unique Device Identification) and Reprocessing Medical Devices Other Medical Device Regulations World-Wide 10
K UDI (Unique Device Identification) requirements of US FDA US Food and Drug Administration (FDA) 4
M UDI (Unique Device Identification) Verification Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
Ajit Basrur ICCBBA Is Now an FDA-Accredited Issuing Agency for Unique Device Identifiers (UDI) Other US Medical Device Regulations 1
C UDI (Unique Device Identifier) Definition of Labeler Other US Medical Device Regulations 1
M Official EU Unique Device Identifier (UDI) Requirements EU Medical Device Regulations 3
Sam Lazzara 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013 - 2015) Other US Medical Device Regulations 45
W Class II Medical Device Unique Device Identifier (UDI) Requirements US Food and Drug Administration (FDA) 8
S US FDA Unique Device Identification (UDI) Proposed Rule 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 18
X FDA UDI (Unique Identification) amendment on 19 Nov 2012 - Date of 'final rule'? US Food and Drug Administration (FDA) 4
V UDI - OEM or OBL / Legal Manufacturer Responsibility CE Marking (Conformité Européene) / CB Scheme 0
A European UDI-DI CE Marking (Conformité Européene) / CB Scheme 2
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 0
M UDI procedure/ report 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
R Shall a new UDI-DI be required when stand-alone software device's version is updated? EU Medical Device Regulations 1
D Hospital Decontamination and the MDR - Technical Files, UDI and PMS EU Medical Device Regulations 3
F UDI - Unit of Use and Class I, single-use devices EU Medical Device Regulations 4
F UDI Registration - Who is responsible for Registration of the Device? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
M UDI Database and EUDAMED - Will there be two separate databases? EU Medical Device Regulations 4
Q Must product name be listed the same name in FURLS, UDI, GUDID and Company Website? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Q LOT or Serial Number Symbol not used when the information is contained in the UDI? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Looking for a template SOP for UDI implementation for EU Medical Devices EU Medical Device Regulations 0
M Basic UDI and technical documentation EU 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
M MDR Requirements - UDI/Barcodes/QR codes on IFUs EU Medical Device Regulations 4
M UDI transition period and implementation EU Medical Device Regulations 6
M UDI size on packaging EU Medical Device Regulations 3
R UDI for US - Third Party device Repackager Other US Medical Device Regulations 9
M UDI placement - Packaging levels EU Medical Device Regulations 2
L UDI Requirments Gap Analysis - EU MDR vs FDA CFR EU Medical Device Regulations 8
M DI format for UDI after we have registered it with GS1 Other US Medical Device Regulations 0
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
K China UDI Implementation for October 1st 2019 China Medical Device Regulations 4
A What is the difference between Basic UDI-DI and UDI-DI? EU Medical Device Regulations 6
M UDI-PI on a package that contains more devices EU Medical Device Regulations 3
F EUDAMED UDI Medical Devices User's Guide Medical Device and FDA Regulations and Standards News 6
J Class 1 Medical Device - Using a UPC over the UDI? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
Z Do we still have to put UDI if we have DI and lot number seperately on our product ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4

Similar threads

Top Bottom