UDI for product already packed up

#1
Dear All,
I have a warehouse full of implantable MD with double packaging, patient card inside but without UDI. From the 26th of May, we are ready to start the production with UDI code in the primary and secondary packaging. But for the products that I have in the warehouse... Have I to rewrapping all and insert the UDI code? or Not? They have been manufactured before the 26th of May....
Thanks for your help
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
S Does a refurbished product required a new UDI? US Food and Drug Administration (FDA) 3
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
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
Pmarszal Two Questions on UDI Product Description (GS1 US and GTIN aspects) Other US Medical Device Regulations 2
L Configurable UDI mdr EU Medical Device Regulations 0
L UDI implementation in Saudi Arabi (KSA) Other Medical Device Regulations World-Wide 0
L UDI-DI - Device will be sold by itself in a box EU Medical Device Regulations 2
P Basic UDI-DI and Legacy Devices EU Medical Device Regulations 7
C UDI for consumable/replacement components under the MDR EU Medical Device Regulations 2
K UDI for two units with different S/N on the same package/case Other US Medical Device Regulations 10
C Validation of process for releasing the UDI EU Medical Device Regulations 4
A MDR requirement where unit of use packaging is too small for UDI carrier EU Medical Device Regulations 1
L UDI needed when we submit to ON? EU Medical Device Regulations 5
M Brand owner or manufacturer responsible for Basic UDI-DI and UDI-DI? EU Medical Device Regulations 6
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 4
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 5
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 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

Similar threads

Top Bottom