UDI - Traceability of Products

acro14

Starting to get Involved
#1
Dear forum members,

my company is a european manufacturer of medical devices. We want to prepare for the upcoming UDI implementation in Europe. In this context I have a question regarding traceability of products after market release: when we sell products to a wholesaler or retailer, e.g. a supermarket or medical supply store, how can traceability be assured? You maybe not know the end customer who bought a product. Are stores obliged to modify their registration systems to fit the UDI scheme?

How is this issue handled in the US? I will appreciate your replies.
 
Elsmar Forum Sponsor

shimonv

Trusted Information Resource
#2
Hello acro14,
You need to be more specific with what you are doing and your questions so that forum members can reply.

I will just point out that UDI and tractability are two different things. They are related but the requirements and implementation are quit different.

Cheers,
Shimon
 
Thread starter Similar threads Forum Replies Date
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
K Is UDI (Unique Device Identifier) symbol mandatory under EU MDR? EU Medical Device Regulations 1
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
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 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
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
M EU MDR - UDI requirements and responsibility guidance EU Medical Device Regulations 1
A UDI requirements for pre-filled combination devices - Box containing a pre-filled device US Food and Drug Administration (FDA) 2
G FDA UDI markings "label" vs. "labelling" (labeling)? US Food and Drug Administration (FDA) 4
N EU MDR Basic UDI-DI and Technical Documentation for Systems EU Medical Device Regulations 22
M Informational MDCG 2019-2 Guidance on application of UDI rules to device-part of products referred to in Article 1(8), 1(9) and 1(10) of Regulation 745/2017 Medical Device and FDA Regulations and Standards News 0
Z UDI assignment Criteria Software IVDR Other Medical Device Regulations World-Wide 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
M UDI labeling MDR requirement for reusable medical device accessories EU Medical Device Regulations 12
M Medical Device News EU interesting developments – embracing MDSAP and UDI alignment Medical Device and FDA Regulations and Standards News 0
M Medical Device News EU – MDCG 2019-1 MDCG guiding principles for issuing entities rules on Basic UDI-DI Medical Device and FDA Regulations and Standards News 0

Similar threads

Top Bottom