Source: https://elsmar.com/elsmarqualityforum/threads/udi-pi-on-a-package-that-contains-more-devices.77052/
Timestamp: 2020-06-03 04:08:18
Document Index: 138780269

Matched Legal Cases: ['art 820', 'art 820', 'art 820', 'art 820', 'art 820', 'art 820', 'art 820', 'art 820', 'art 820']

UDI-PI on a package that contains more devices
Thread starter med_cert
med_cert
In IMDRF UDI WG's "Unique Device Identification system (UDI system) Application Guide" from 21 March 2019, the folowing example is presented
Example 2: A manufacturer manufactures two versions/models​
of a device. Model A is more popular than Model B. To sell​
more of Model B, the two models, when sent to retailers and​
distributors, are packaged in an assorted case that always​
includes 5 of Model A and 3 of Model B, i.e. a standard configuration.​
Although both devices may have similar indications for use,​
Model A and Model B were not combined in a device package​
with the intent they are used together to achieve a common​
intended use. Rather, these two or more different​
models/versions of devices were packaged together for business reasons.​
This package configuration itself is neither a device nor a kit but a shipping configuration.​
However, to adequately identify this fixed configuration through distribution and use, packages require UDI.​
Recommended best practice is to place a UDI on each device in the packaging configuration and​
place a UDI on the package that contains the devices.​
What UDI-PI should be placed on UDI of this package (if each of those two devices have their seperate UDI-PI...)?
DI as the unique identifier for that package configuration
PI as the date on which it was packed, which leads you back to the original manufacturing lot #s for each part.
Thanks, that was also my assumption... however, I don't see any benefit... each part already has tracks to the original manufacturing... I really don't see the reason why this PI should be important (I hope it has some deeper purpuse not only because it's written so... )
Reed Tech has an eBook that walks you through assigning DI's for packaging (my go-to reference). You can download for free at the link below.
UDI: How do I assign Device Identifiers? | Reed Tech
F UDI Registration - Who is responsible for Registration of the Device? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6 May 14, 2020
M UDI Database and EUDAMED - Will there be two separate databases? EU Medical Device Regulations 3 Apr 22, 2020
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 Feb 20, 2020
M Basic UDI and technical documentation EU Medical Device Regulations 1 Feb 7, 2020
M MDR Requirements - UDI/Barcodes/QR codes on IFUs EU Medical Device Regulations 4 Dec 3, 2019
M UDI transition period and implementation EU Medical Device Regulations 6 Nov 14, 2019
M UDI size on packaging EU Medical Device Regulations 3 Nov 8, 2019
R UDI for US - Third Party device Repackager Other US Medical Device Regulations 9 Nov 4, 2019
M UDI placement - Packaging levels EU Medical Device Regulations 2 Oct 28, 2019
M DI format for UDI after we have registered it with GS1 Other US Medical Device Regulations 0 Oct 16, 2019
P UDI labeling for power module IEC 60601 - Medical Electrical Equipment Safety Standards Series 6 Sep 24, 2019
UDI, Labeling Accessories, General Insanity, Etc. US Food and Drug Administration (FDA) 1 Sep 20, 2019
K China UDI Implementation for October 1st 2019 China Medical Device Regulations 4 Aug 30, 2019
A What is the difference between Basic UDI-DI and UDI-DI? EU Medical Device Regulations 5 Aug 27, 2019
M Informational EU – Unique Device Identification (UDI) System – FAQs Medical Device and FDA Regulations and Standards News 0 Aug 12, 2019
F EUDAMED UDI Medical Devices User's Guide Medical Device and FDA Regulations and Standards News 6 Aug 10, 2019
J Class 1 Medical Device - Using a UPC over the UDI? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0 Aug 8, 2019
M EU Basic UDI-DI Trigger Points - When is a new Basic UDI-DI required EU Medical Device Regulations 3 Jul 31, 2019
P UDI-PI and the MDR - Is the UDI-PI required for all devices/classifications? EU Medical Device Regulations 4 Jun 21, 2019
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 May 22, 2019
K Hospital UDI requirements Other Medical Device and Orthopedic Related Topics 7 May 16, 2019
J FDA Class 1 Medical Device UDI requirements Other US Medical Device Regulations 19 May 10, 2019
J UDI Requirements - Products that all fall under the same family 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3 May 9, 2019
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 May 8, 2019
F MDR 2017/745 Basic UDI-DI, UDI-DI & UDI-PI EU Medical Device Regulations 0 May 8, 2019
M Informational EU – EUDAMED UDI Device Data Dictionary + data sets Medical Device and FDA Regulations and Standards News 0 May 3, 2019
M EU MDR - UDI requirements and responsibility guidance EU Medical Device Regulations 1 May 3, 2019
A UDI requirements for pre-filled combination devices - Box containing a pre-filled device US Food and Drug Administration (FDA) 2 Apr 30, 2019
G FDA UDI markings "label" vs. "labelling" (labeling)? US Food and Drug Administration (FDA) 4 Apr 29, 2019
N EU MDR Basic UDI-DI and Technical Documentation for Systems EU Medical Device Regulations 22 Mar 18, 2019
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 Feb 19, 2019
Z UDI assignment Criteria Software IVDR Other Medical Device Regulations World-Wide 0 Feb 12, 2019
S Looking for procedure on UDI (Unique Device Identification) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1 Feb 11, 2019
S UDI (Unique Device Identification) Requirements for Remanufactured devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1 Feb 10, 2019
M UDI labeling MDR requirement for reusable medical device accessories EU Medical Device Regulations 12 Feb 1, 2019
M Medical Device News EU interesting developments – embracing MDSAP and UDI alignment Medical Device and FDA Regulations and Standards News 0 Jan 31, 2019
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 Jan 29, 2019
S Understanding UDI requirements - Class 2 medical device (hearing aids) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3 Jan 23, 2019
S Is Lot Number required in addition to UDI serial number? Other Medical Device Regulations World-Wide 7 Dec 6, 2018
UDI for former manufacturer - My company is a distributor Other US Medical Device Regulations 0 Dec 5, 2018
M Medical Device News FDA Guidance - UDI: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking Other US Medical Device Regulations 0 Nov 2, 2018
S Medical device mobile app UDI - Where is the UDI labelled? Other US Medical Device Regulations 1 Oct 26, 2018
N Will an FDA UDI be compatible with a European MDR UDI? EU Medical Device Regulations 7 Oct 26, 2018
S What is the significance of UDI date requirements for Class 1 devices? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4 Sep 19, 2018
K UDI Labeling for Medical Device Samples 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2 Sep 18, 2018
UDI Registration - Who is responsible for Registration of the Device?
UDI Database and EUDAMED - Will there be two separate databases?
LOT or Serial Number Symbol not used when the information is contained in the UDI?
Basic UDI and technical documentation
MDR Requirements - UDI/Barcodes/QR codes on IFUs
UDI transition period and implementation
UDI size on packaging
UDI for US - Third Party device Repackager
UDI placement - Packaging levels
DI format for UDI after we have registered it with GS1
UDI labeling for power module
UDI, Labeling Accessories, General Insanity, Etc.
China UDI Implementation for October 1st 2019
What is the difference between Basic UDI-DI and UDI-DI?
Informational EU – Unique Device Identification (UDI) System – FAQs
EUDAMED UDI Medical Devices User's Guide
Class 1 Medical Device - Using a UPC over the UDI?
EU Basic UDI-DI Trigger Points - When is a new Basic UDI-DI required
UDI-PI and the MDR - Is the UDI-PI required for all devices/classifications?
Informational US FDA issued the first warning letter for UDI violations to help ensure compliance
Hospital UDI requirements
UDI Requirements - Products that all fall under the same family
Informational EU – MDCG 2018-1 v2 Guidance on basic UDI-DI and changes to UDI-DI
MDR 2017/745 Basic UDI-DI, UDI-DI & UDI-PI
Informational EU – EUDAMED UDI Device Data Dictionary + data sets
EU MDR - UDI requirements and responsibility guidance
UDI requirements for pre-filled combination devices - Box containing a pre-filled device
FDA UDI markings "label" vs. "labelling" (labeling)?
EU MDR Basic UDI-DI and Technical Documentation for Systems
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
UDI assignment Criteria Software IVDR
Looking for procedure on UDI (Unique Device Identification)
UDI (Unique Device Identification) Requirements for Remanufactured devices
UDI labeling MDR requirement for reusable medical device accessories
Medical Device News EU interesting developments – embracing MDSAP and UDI alignment
Medical Device News EU – MDCG 2019-1 MDCG guiding principles for issuing entities rules on Basic UDI-DI
Understanding UDI requirements - Class 2 medical device (hearing aids)
Is Lot Number required in addition to UDI serial number?
UDI for former manufacturer - My company is a distributor
Medical Device News FDA Guidance - UDI: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking
Medical device mobile app UDI - Where is the UDI labelled?
Will an FDA UDI be compatible with a European MDR UDI?