Regulatory Open Forum

"EU MDR Art.22 System/Procedure Pack Basic UDI-DI Concept"

Can one device have two system BUDIs?

The general rule for BUDI at the product level is that one Device must always be associated with only one Basic UDI-DI. When it comes to the System BUDI required under MDR Art. 29, rather than the guidance that focus on BUDI, only the SSCP Guidance document MDCG 2019-9 mentions (section 3.1) that one Device can have one product BUDI and a System BUDI (when Art. 22 definition of System/Procedure Pack (S/PP) is met).

However, if one Device is part of two separate Systems, then the Device would require one product BUDI and two System BUDIs. Does this contradict the "one Device must always be associated with one and only one Basic UDI-DI" notion, or this does not apply since we are talking about System BUDI only?

Thanks.

Hi Anon,

as far as I can see: Yes.

The Basic UDI-DI assigned to the system/procedure pack (assuming that it is not a device in itself) is independent from the Basic UDI-DIs of the devices the system/procedure pack contains. If three different system/procedure pack producers (SPPP) decide to use the identical device (among others) as part of their system/procedure pack, then each SPPP would assign their own Basic UDI-DI and the device itself would keep the Basic UDI-DI assigned by its manufacturer. At least that is my current understanding.

Best regards

Christoph

"EU MDR Art.22 System/Procedure Pack Basic UDI-DI Concept"

Can one device have two system BUDIs?

The general rule for BUDI at the product level is that one Device must always be associated with only one Basic UDI-DI. When it comes to the System BUDI required under MDR Art. 29, rather than the guidance that focus on BUDI, only the SSCP Guidance document MDCG 2019-9 mentions (section 3.1) that one Device can have one product BUDI and a System BUDI (when Art. 22 definition of System/Procedure Pack (S/PP) is met).

However, if one Device is part of two separate Systems, then the Device would require one product BUDI and two System BUDIs. Does this contradict the "one Device must always be associated with one and only one Basic UDI-DI" notion, or this does not apply since we are talking about System BUDI only?

Thanks.

Hi Christoph,

Thanks for your reply.

I would agree with your understanding. In practice, I also see the possibility that one Device would be part of different S/PPs. However, there is no clear (legal) guidance to back this up...Just not sure how one can argue this.

Kind regards,

Hi Anon,

as far as I can see: Yes.

The Basic UDI-DI assigned to the system/procedure pack (assuming that it is not a device in itself) is independent from the Basic UDI-DIs of the devices the system/procedure pack contains. If three different system/procedure pack producers (SPPP) decide to use the identical device (among others) as part of their system/procedure pack, then each SPPP would assign their own Basic UDI-DI and the device itself would keep the Basic UDI-DI assigned by its manufacturer. At least that is my current understanding.

Best regards

Christoph

"EU MDR Art.22 System/Procedure Pack Basic UDI-DI Concept"

Can one device have two system BUDIs?

The general rule for BUDI at the product level is that one Device must always be associated with only one Basic UDI-DI. When it comes to the System BUDI required under MDR Art. 29, rather than the guidance that focus on BUDI, only the SSCP Guidance document MDCG 2019-9 mentions (section 3.1) that one Device can have one product BUDI and a System BUDI (when Art. 22 definition of System/Procedure Pack (S/PP) is met).

However, if one Device is part of two separate Systems, then the Device would require one product BUDI and two System BUDIs. Does this contradict the "one Device must always be associated with one and only one Basic UDI-DI" notion, or this does not apply since we are talking about System BUDI only?

Thanks.

Hi Anon,

the way the MDR integrates the UDI concepts is frustratingly complicated and far from perfect. Maybe the following considerations help:

Although the MDR requires a Basic UDI-DI for devices as well as for systems/procedure packs, these two assignments are (in my opinion) independent from each other.

For a device, the manufacturer assigns the Basic UDI-DI for registration and regulatory purposes (Article 29(1)) and then includes individual devices with their UDI-DI under this registered Basic UDI-DI (Article 27(3)). As you correctly stated there must be exactly one Basic UDI-DI for each device (as far as I can see that is not explicitly stated in the MDR, but MDCG 2018-1 states that "Any Basic-UDI shall identify the devices covered by thad Basic UDI-DI in a unique manner", with the caveat that the guidance does not address requirements for "[...] systems or procedure packs [...]"). The EU chose to integrate the product registration and UDI database into a single module of EUDAMED, and the database should make sure that you can assign each UDI-DI to exactly one Basic UDI-DI.

For a system or procedure pack, the SPPP assigns the Basic UDI-DI for registration (Article 29(2)) and then includes individual systems/procedure packs with their UDI-DI under this registered Basic UDI-DI (this requirement is not explicitly stated in one of the Articles, but Annex 6 3.7 and 6.3.1 imply it as mentioned in MDCG 2018-3). Although MDCG 2018-1 excludes systems and procedure packs I assume that the general rules are the same: Each UDI-DI for an individual system/procedure pack must be connected to exactly one Basic UDI-DI for a respective system/procedure pack. 

When registring the Basic UDI-DI and the individual UDI-DI of a system/procedure pack, no information on the contained, individual devices is required (the requirend information for systems/procedure packs is not that clear in Annex VI part A, because here they seem to have forgotten about them, but MDCG 2018-4 clarifies that).

Because individual devices in a system/procedure pack must be MDR compliant, they each carry their own, device specific UDI-DI that is assigned to the respective device Basic UID-DI that was assigned by the manufacturer (for the UDI carrier see Annex VI 6.3.2 that fails to clarify that the carrier on the individual devices of course must bear the device UDI-DI not the system/procedure pack UDI-DI). But there is no connection in EUDAMED between the procedure pack (Basic) UDI-DI and the individual device (Basic) UDI-DI.

In consequence - as far as I can see - there is no formal assignment of an individual device UDI-DI to a system/procedure pack Basic UDI-DI that would go against the one device - one Basic UDI-DI rule. In EUDAMED, the Basic UDI-DI and UDI-DI of the devices and the system/procedure pack are separated.

Some indication of the UDI assignment of devices and systems/procedure packs being unrelated can also be found in MDCG 2018-3 under section 5 where it is stated that the Basic UDI-DI assignment is done "regardless of the original components manufacturers".

In consequence: Although I cannot point to a single provision in the MDR or an explicit MDCG guidance document, I think there is sufficient evidence that you can indeed have one device (with its own properly assigned UDI-DI and Basic UDI-DI) in several systems/procedure packs (each with their own properly assigned UDI-DI and Basic UDI-DI) without having a problem in Basic UDI-DI assignment.

I am not sure, if this clarifies or confuses things. If something remains unclear, just let me know.

Best regards

Christoph

Hi Christoph,

Thanks for your reply.

I would agree with your understanding. In practice, I also see the possibility that one Device would be part of different S/PPs. However, there is no clear (legal) guidance to back this up...Just not sure how one can argue this.

Kind regards,

Hi Anon,

as far as I can see: Yes.

The Basic UDI-DI assigned to the system/procedure pack (assuming that it is not a device in itself) is independent from the Basic UDI-DIs of the devices the system/procedure pack contains. If three different system/procedure pack producers (SPPP) decide to use the identical device (among others) as part of their system/procedure pack, then each SPPP would assign their own Basic UDI-DI and the device itself would keep the Basic UDI-DI assigned by its manufacturer. At least that is my current understanding.

Best regards

Christoph

"EU MDR Art.22 System/Procedure Pack Basic UDI-DI Concept"

Can one device have two system BUDIs?

The general rule for BUDI at the product level is that one Device must always be associated with only one Basic UDI-DI. When it comes to the System BUDI required under MDR Art. 29, rather than the guidance that focus on BUDI, only the SSCP Guidance document MDCG 2019-9 mentions (section 3.1) that one Device can have one product BUDI and a System BUDI (when Art. 22 definition of System/Procedure Pack (S/PP) is met).

However, if one Device is part of two separate Systems, then the Device would require one product BUDI and two System BUDIs. Does this contradict the "one Device must always be associated with one and only one Basic UDI-DI" notion, or this does not apply since we are talking about System BUDI only?

Thanks.

Hi Christoph,

Thanks for your reply.

I would agree with your understanding. In practice, I also see the possibility that one Device would be part of different S/PPs. However, there is no clear (legal) guidance to back this up...Just not sure how one can argue this.

Kind regards,

Hi Anon,

as far as I can see: Yes.

The Basic UDI-DI assigned to the system/procedure pack (assuming that it is not a device in itself) is independent from the Basic UDI-DIs of the devices the system/procedure pack contains. If three different system/procedure pack producers (SPPP) decide to use the identical device (among others) as part of their system/procedure pack, then each SPPP would assign their own Basic UDI-DI and the device itself would keep the Basic UDI-DI assigned by its manufacturer. At least that is my current understanding.

Best regards

Christoph

"EU MDR Art.22 System/Procedure Pack Basic UDI-DI Concept"

Can one device have two system BUDIs?

The general rule for BUDI at the product level is that one Device must always be associated with only one Basic UDI-DI. When it comes to the System BUDI required under MDR Art. 29, rather than the guidance that focus on BUDI, only the SSCP Guidance document MDCG 2019-9 mentions (section 3.1) that one Device can have one product BUDI and a System BUDI (when Art. 22 definition of System/Procedure Pack (S/PP) is met).

However, if one Device is part of two separate Systems, then the Device would require one product BUDI and two System BUDIs. Does this contradict the "one Device must always be associated with one and only one Basic UDI-DI" notion, or this does not apply since we are talking about System BUDI only?

Thanks.

Christoph Kiesselback goes deeply into the details of the MDR. However, there is another way to approach this. Different economic operator roles come with different authorities and responsibilities. The manufacturer can assign a Basic UDI-DI and UDI-DI to a device and the System and Procedure Pack Producer (SPPP) from Article 22 can assign a Basic UDI-DI and UDI-DI to system or procedure pack. They can do that independently from eachother. 

You appear to be looking for articles in the MDR and/or MDCG guidance about this. My approach is, that I cannot find anything supporting the opposite. Therefore, it is possible for one Basci UDI-DI of a device to be linked to multiple System or Procedure Pack Basic UDI-DI. 

Hi Christoph,

Thanks for your reply.

I would agree with your understanding. In practice, I also see the possibility that one Device would be part of different S/PPs. However, there is no clear (legal) guidance to back this up...Just not sure how one can argue this.

Kind regards,

Hi Anon,

as far as I can see: Yes.

The Basic UDI-DI assigned to the system/procedure pack (assuming that it is not a device in itself) is independent from the Basic UDI-DIs of the devices the system/procedure pack contains. If three different system/procedure pack producers (SPPP) decide to use the identical device (among others) as part of their system/procedure pack, then each SPPP would assign their own Basic UDI-DI and the device itself would keep the Basic UDI-DI assigned by its manufacturer. At least that is my current understanding.

Best regards

Christoph

"EU MDR Art.22 System/Procedure Pack Basic UDI-DI Concept"

Can one device have two system BUDIs?

The general rule for BUDI at the product level is that one Device must always be associated with only one Basic UDI-DI. When it comes to the System BUDI required under MDR Art. 29, rather than the guidance that focus on BUDI, only the SSCP Guidance document MDCG 2019-9 mentions (section 3.1) that one Device can have one product BUDI and a System BUDI (when Art. 22 definition of System/Procedure Pack (S/PP) is met).

However, if one Device is part of two separate Systems, then the Device would require one product BUDI and two System BUDIs. Does this contradict the "one Device must always be associated with one and only one Basic UDI-DI" notion, or this does not apply since we are talking about System BUDI only?

Thanks.