UDI- RFID Labeling

Q

QAengineer13

Quite Involved in Discussions
#1
#1
Dear all,

In my current project we are thinking of using the RFID for UDI, could you please share with the me your experience on implementing the labeling requirements for UDI using RFID.

Thanks in advance! :thanx:
 
Quickly Organize an Intelligent TDP from DISCUS
Elsmar Forum Sponsor
M

miken99

#2
#2
Healthcare companies have decided to focus on barcode at this point. RFID will probably follow in years to come.
I suggest you check with your customers before going too far. You could be out on a limb......alone. They may not have the required infrastructure, readers, antennas, software, etc. Plus, RFID is tricky and not nearly as precise and mature as barcode.
 
A

Al Rosen

Staff member
Super Moderator
#5
#5
miken99 said:
Al,
search for 'direct marking' in the federal register posting of the FDA rule and you will see what and why
Click to expand...
Got it
801.45c2
Automatic identification and data capture (AIDC) technology, or any alternative technology, that will provide the UDI of the device on demand.

Thanks.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Brand owner or manufacturer responsible for Basic UDI-DI and UDI-DI? EU Medical Device Regulations 1
Aymaneh UDI-PI Software CE Marking (Conformité Européene) / CB Scheme 0
J UDI-DI how should we interpret Device version or model to determine if a new UDI-DI is needed? EU Medical Device Regulations 0
P UDI-PI requirements on reusable surgical device, do we need serialisation? ISO 13485:2016 - Medical Device Quality Management Systems 3
J UDI - Where to document it? EU Medical Device Regulations 8
N UDI: GS1 or HIBC ??? EU Medical Device Regulations 1
F UDI-PI required on packaging (MDR) EU Medical Device Regulations 2
C UDI Questions on Control Units Other US Medical Device Regulations 6
M Supplier requirements - Major supplier is a Non-Profit registered with ICCBBA (FDA UDI) Supply Chain Security Management Systems 12
K Two FDA questions regarding UDI (and potentially 803.52 MDR) Other US Medical Device Regulations 0
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 1
K Is UDI (Unique Device Identifier) symbol mandatory under EU MDR? EU Medical Device Regulations 3
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 1
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
M Informational EU – Unique Device Identification (UDI) System – FAQs Medical Device and FDA Regulations and Standards News 0
F EUDAMED UDI Medical Devices User's Guide Medical Device and FDA Regulations and Standards News 7
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
M EU Basic UDI-DI Trigger Points - When is a new Basic UDI-DI required EU Medical Device Regulations 3
P UDI-PI and the MDR - Is the UDI-PI required for all devices/classifications? EU Medical Device Regulations 8
M Informational US FDA issued the first warning letter for UDI violations to help ensure compliance Medical Device and FDA Regulations and Standards News 0
K Hospital UDI requirements Other Medical Device and Orthopedic Related Topics 7
J FDA Class 1 Medical Device UDI requirements Other US Medical Device Regulations 19
J UDI Requirements - Products that all fall under the same family 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Informational EU – MDCG 2018-1 v2 Guidance on basic UDI-DI and changes to UDI-DI Medical Device and FDA Regulations and Standards News 0
F MDR 2017/745 Basic UDI-DI, UDI-DI & UDI-PI EU Medical Device Regulations 0
M Informational EU – EUDAMED UDI Device Data Dictionary + data sets Medical Device and FDA Regulations and Standards News 0

Similar threads

Top Bottom