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EU MDR Basic UDI-DI and Technical Documentation for Systems

N

Nancy Harvey

#1
We are confused about Basic UDI-DI and would like some input on how you're all handling this, especially if you document systems that consist of a system and dependent accessories. In our case, we have monitors and dependent accessories that record things like blood pressure, oxygen saturation, pulse, and temperature. The monitor is meaningless without the accessories, and the accessories can't work without the monitor. Getting back to Basic UDI-DI, we're confused about whether we need to create a multitude of technical files for each accessory group (intended purpose and risk classification), or whether we can follow our MDD model of a system technical file with monitor and accessories, but have multiple DoCs, one for each Basic UDI-DI that applies using the criteria of intended use and risk class. Anyone run into this situation, and if so, how have you handled it?
 
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S

SYRANE

#2
I agree with you this is very confusing. On our side we have a read-out module and several probes with different sizes. I consider these coverd by the same basic UDI-DI (same design file, same technical file, same risk class, same intended purpose). Than, each module & probe has its specific UDI-DI. This means that under one basic UDI-DI I will cover all UDI-DI.
 
N

Nancy Harvey

#3
Thank you, Syrane. How will you handle Annex IV? Will you have one Declaration of Conformity or multiple Declarations of Conformity, each with its own Basic UDI-DI?
 
G

gauravkapila

#4
Thank you, Syrane. How will you handle Annex IV? Will you have one Declaration of Conformity or multiple Declarations of Conformity, each with its own Basic UDI-DI?
We have quite similar stuff like we have an instrument (analyzer) and it has lots of accompanying"accessories" and "components". We are keeping just one tech file for all of these as well as just one DoC but the DoC indexes the name, part number, GMDN code of the instrument in the top table and then there is another table that mentions the accessories with the names, part number, GMDN info
 
S

SYRANE

#5
Same for us. As we have already the UDI in place, we are sticking a copy of the UDI labels of the different parts that are delivered on the DoC. At the end of the DoC we are listing all product codes (for the different modules & probes) with all corresponding UDI-DI. This allows us to have only one DoC. What worries me more is the last document that was edited by the MDCG (MDCG 2019-5) concerning the registration of lecacy devices in Eudamed (attached file). We have for example a certificate under the MDD that goes until 2023. However, we already have a UDI system in place using Gs1 as accredited agency. Indeed, we had to put this UDI system in place for the USA like a number of other manufacturers. According to this MDCG 2019-5 document as long as our equipments are not certified under the MDR we have to register them in EUDAMED (no problem) BUT it is EUDAMED which is going to assign us a basic UDI-DI as well as all UDI-DIs. How should we handle this? Will we have to integrate 2 UDIs on our labels (the EUDAMED one which will be unknown by interested parties outside Europe and the Gs1 accredited UDI which is a perfect tracability tool?)
I am wondering if european experts know about MD industry and what is going on outside Europe! Real-World experts would be great!
 

Attachments

S

SYRANE

#7
Why not? We are moving away from the UDI concept of allowing tracability of a product. The UDImust be linked to a product nota regulation. Indeed, Annex VI Part C point 5.5 recalls that a UDI is not a proof of compliance with the MDR.
 
#8
Ironically, I just ran into this today while trying to create the process and template for the SSCP. Ac cording to MDCG Guidance Document on the SSCP, the UDI-DI of a "system" is the only one that should be referenced in the SSCP - the component's individual UDI-DI should be 'transparent" to the end user.

I understand that for various reasons, but there is a TD "sampling" method mentioned meaning that the system may receive a DoC without the NB having reviewed the individual component's UDI-DI and corresponding SSCP (if applicable). Then there is a revision history and a part of that is supposed to include when a component is validated by the NB.

For transparency, to me that means that the revision history will not be published on Eudamed? In addition, in the device description per the Guidance Document states:

"In Eudamed, the SSCP is associated to one unique Basic UDI-DI. All UDI- DIs/devices associated to this Basic UDI-DI will be seen as having the same SSCP (a UDI-DI/device must always be associated with one and only one Basic UDI-DI).

If the device is a system of several components/devices, each device in the system should have a Basic UDI-DI but also one Basic UDI-DI for the system. It is the Basic UDI-DI for the system that is intended to be provided in section 1.4 in the template, and that will be associated with the SSCP in Eudamed. The device system, and any Basic UDI-DIs of included devices, should be described in section 3.1."

It entirely possible that I cannot see the "forest through the trees" at the moment, but that seems to be in conflict? the individual UDI-DIs should still be a part of the SSCP? But for transparency, only the system UDI-DI should be shown?

I understand that the original question was for a different purpose, but it seems it is all related or will be?

Thanks - any feedback is appreciated!
 
K

Kathy Moon

#9
We have quite similar stuff like we have an instrument (analyzer) and it has lots of accompanying"accessories" and "components". We are keeping just one tech file for all of these as well as just one DoC but the DoC indexes the name, part number, GMDN code of the instrument in the top table and then there is another table that mentions the accessories with the names, part number, GMDN info
This is so helpful to me because I am dealing with a system for a procedure and that system includes a parent device and then a couple of other components (measuring device and surgical instruments for cutting etc.). I did not know if I should have one DOC which would show all parts of the system. However, each part of the system is also sold separately as replacements etc. Do we need a separate DOC for each part of the system for this purpose? Or, can we simply use the one DOC which includes the parent device and components...?
 
#10
Ironically, I just ran into this today while trying to create the process and template for the SSCP. Ac cording to MDCG Guidance Document on the SSCP, the UDI-DI of a "system" is the only one that should be referenced in the SSCP - the component's individual UDI-DI should be 'transparent" to the end user.

I understand that for various reasons, but there is a TD "sampling" method mentioned meaning that the system may receive a DoC without the NB having reviewed the individual component's UDI-DI and corresponding SSCP (if applicable). Then there is a revision history and a part of that is supposed to include when a component is validated by the NB.

For transparency, to me that means that the revision history will not be published on Eudamed? In addition, in the device description per the Guidance Document states:

"In Eudamed, the SSCP is associated to one unique Basic UDI-DI. All UDI- DIs/devices associated to this Basic UDI-DI will be seen as having the same SSCP (a UDI-DI/device must always be associated with one and only one Basic UDI-DI).

If the device is a system of several components/devices, each device in the system should have a Basic UDI-DI but also one Basic UDI-DI for the system. It is the Basic UDI-DI for the system that is intended to be provided in section 1.4 in the template, and that will be associated with the SSCP in Eudamed. The device system, and any Basic UDI-DIs of included devices, should be described in section 3.1."

It entirely possible that I cannot see the "forest through the trees" at the moment, but that seems to be in conflict? the individual UDI-DIs should still be a part of the SSCP? But for transparency, only the system UDI-DI should be shown?

I understand that the original question was for a different purpose, but it seems it is all related or will be?

Thanks - any feedback is appreciated!
Hi Valerie,

I was just wondering if you could advice where the below excerpt has been taken from please? I couldn't find it any of the sources I browsed;

"In Eudamed, the SSCP is associated to one unique Basic UDI-DI. All UDI- DIs/devices associated to this Basic UDI-DI will be seen as having the same SSCP (a UDI-DI/device must always be associated with one and only one Basic UDI-DI).

If the device is a system of several components/devices, each device in the system should have a Basic UDI-DI but also one Basic UDI-DI for the system. It is the Basic UDI-DI for the system that is intended to be provided in section 1.4 in the template, and that will be associated with the SSCP in Eudamed. The device system, and any Basic UDI-DIs of included devices, should be described in section 3.1."

Thank you
Kind Regards,
Ajanta
 
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