UDI-PI and the MDR - Is the UDI-PI required for all devices/classifications?

pkost

Trusted Information Resource
#1
Is the UDI-PI required for all devices/classifications? or is it acceptable for some products to only include the UDI-DI component on the product packaging?
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
As general info for people like me who don't know all the acronyms:

UDI-PI - The UDI-PI is used to identify specific production series of a medical device (batch, serial number etc.). In case of minor non-relevant changes the UDI-PI will can also be used for identification of specific generations of the device. However, the UDI-PI cannot be used to replace different UDI-DIs.

UDI-DI - In Annex VI, Part C of Medical Devices Regulation 2017/745, the Basic UDI-DI is defined as: “… the primary identifier of a device model. It is the DI assigned at the level of the device unit of use. It is the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity.” The guidance document specifies this further: “devices with same intended purpose, risk class and essential design and manufacturing characteristics.”

Info from Emergo.
 
Last edited:

François

Involved In Discussions
#4
To my knowledge, there is only one exception in Annex VI Section C:
"For single-use devices of classes I and IIa packaged and labelled individually, the UDI carrier shall not be required to appear on the packaging but it shall appear on a higher level of packaging, e.g. a carton containing several individually packaged devices. However, when the healthcare provider is not expected to have access, in cases such as in home healthcare settings, to the higher level of device packaging, the UDI shall be placed on the packaging of the individual device."

Otherwise the UDI-PI is mandatory on packaging no matter what is the device classification. Which makes sense since it will be used for traceability and vigilance.
 

Krishna Priya T

Starting to get Involved
#5
What are the elements UDI-PI should have? As per MDR Annex VI, part C, 3.5 - If a lot number, serial number, software identification or expiry date appears on the label, it shall be part of the UDI-PI. If there is also a manufacturing date on the label, it does not need to be included in the UDI-PI. If there is only a manufacturing date on the label, this shall be used as the UDI-PI.

What does it interpret? which below cases apply?
1. If a lot number, serial number, software identification or expiry date and date of manufacturing are mentioned in label, date of manufacturing is not required to mention in UDI-PI?
2. If a lot number, serial number, software identification or date of manufacturing are mentioned in label, date of manufacturing is required to mention in UDI-PI?
3. If the only date of manufacturing is mentioned in label, date of manufacturing is required to mention in UDI-PI?

Are they any other interpretation?
 

MedicalDevice123

Regulatory affairs specialist
#6
Hi, I know the discussion is a bit old, but here is my response/question:

If you sell in the EU, look at:
MDR GSPR 23.2.
(j) where there is no indication of the date until when it may be used safely, the date of manufacture. This date of manufacture may be included as part of the lot number or serial number, provided the date is clearly identifiable;

MDR GSPR 23.3.: Information on the packaging which maintains the sterile condition of a device (‘sterile packaging’). The following particulars shall appear on the sterile packaging:
(h) the month and year of manufacture,

If you sell in USA, then look at:
§801.40 Form of a unique device identifier.
- (b) The UDI must include a device identifier segment. Whenever a device label includes a lot or batch number, a serial number, a manufacturing date, an expiration date, or for a human cell, tissue, or cellular or tissue-based product (HCT/P) regulated as a device, a distinct identification code as required by §1271.290(c) of this chapter, the UDI must include a production identifier segment that conveys such information.

So that would mean what is on the label, should also be in the UDI. We made the conclusion that, to be compliant with MDR, reusable devices need to have manufacturing date on the label, and pouchlabels of sterile devices need to have the manufacturingdate on the pouchlabel. When we also want to export to the USA, the manufacturingdate should also be included in the UDI for both reusable and sterile devices.

Any other thoughts? Thank you!
 

Kuldeep Singh

Involved In Discussions
#7
As per Annex VI "Part B" of EU MDR (EU 2017/745), there is requirement of SRN (Single Registeration Number) which will provide to UDI Database. As per my understanding, EUDAMED is not implemented this year and not expected to next year.

Can anyone guide me, can we implement the UDI on our device without SRN as we are planing to submit one of our device as per MDR and we are in contact with GS1 (issuing entity as suggested by EU).
 

François

Involved In Discussions
#8
The SRN is not involved in the creation of the UDI so it's not a blocker for UDI implementation.
In my UDI-DI files that lists all information required by Eudamed, I've only add : not available yet for the SRN number. (My TeD has not been reviewed yet by NB).
 

Kuldeep Singh

Involved In Discussions
#9
Thanks Francois for your response , I will do the same for UDI implementations. I hope NB's do not questioning for it as they were also known about the SRN and EUDAMED status.
 
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