Regulatory Open Forum

Hello RAPS Community,

If software versioning scheme is as follow: X.Y.Z where, X= major release, Y=low frequency updates (minor), Z= high frequency updates e.g. bugfixes; does a manufacturer of class I MD software should prepare the DoC for each software version e.g. 3 (X), 3.1 (X.Y) 3.1.1 (X.Y.Z)?

Same question regarding Letter to File: should letter to file be created for each above version independently?

Hello RAPS Community,

If software versioning scheme is as follow: X.Y.Z where, X= major release, Y=low frequency updates (minor), Z= high frequency updates e.g. bugfixes; does a manufacturer of class I MD software should prepare the DoC for each software version e.g. 3 (X), 3.1 (X.Y) 3.1.1 (X.Y.Z)?

Same question regarding Letter to File: should letter to file be created for each above version independently?

Hello RAPS Community,

If software versioning scheme is as follow: X.Y.Z where, X= major release, Y=low frequency updates (minor), Z= high frequency updates e.g. bugfixes; does a manufacturer of class I MD software should prepare the DoC for each software version e.g. 3 (X), 3.1 (X.Y) 3.1.1 (X.Y.Z)?

Same question regarding Letter to File: should letter to file be created for each above version independently?

Our NB took a very strict stance and requires us to have full SW identifier in the DoC. Their basis was that MDR requires "unambiguous reference allowing identification and traceability". Therefore, we write all three digits in the DoC from now on. 

Hello RAPS Community,

If software versioning scheme is as follow: X.Y.Z where, X= major release, Y=low frequency updates (minor), Z= high frequency updates e.g. bugfixes; does a manufacturer of class I MD software should prepare the DoC for each software version e.g. 3 (X), 3.1 (X.Y) 3.1.1 (X.Y.Z)?

Same question regarding Letter to File: should letter to file be created for each above version independently?

Hi Hannes,

thanks for sharing that information.

Out of curiousity: Did the NB address how they interpret the next sentence of Annex IV (4) (where I think the "unambiguous" quote comes from) that states: "Except for the product or trade name, the information allowing identification and traceability may be provided by the Basic UDI-DI referred to in point 3."? Because referencing the Basic UDI-DI as a suitable unambiguous reference does not necessarily reflect the need to include a SW identifier down to the last digit.

Best regards, Christoph

Our NB took a very strict stance and requires us to have full SW identifier in the DoC. Their basis was that MDR requires "unambiguous reference allowing identification and traceability". Therefore, we write all three digits in the DoC from now on. 

Hello RAPS Community,

If software versioning scheme is as follow: X.Y.Z where, X= major release, Y=low frequency updates (minor), Z= high frequency updates e.g. bugfixes; does a manufacturer of class I MD software should prepare the DoC for each software version e.g. 3 (X), 3.1 (X.Y) 3.1.1 (X.Y.Z)?

Same question regarding Letter to File: should letter to file be created for each above version independently?

I think they did not consider Basic UDI-DI adequate to distinquish between different software versions, as different versions can be placed on the market at the same time. Let's say 1.7.6 and 1.7.7 are on the market at the same time, the have the same basic UDI-DI, so how you differentiate between the two.

Something along that lines was their reasoning, and we decided not to challenge it as it's pretty easy to write a DoC.

Hi Hannes,

thanks for sharing that information.

Out of curiousity: Did the NB address how they interpret the next sentence of Annex IV (4) (where I think the "unambiguous" quote comes from) that states: "Except for the product or trade name, the information allowing identification and traceability may be provided by the Basic UDI-DI referred to in point 3."? Because referencing the Basic UDI-DI as a suitable unambiguous reference does not necessarily reflect the need to include a SW identifier down to the last digit.

Best regards, Christoph

Our NB took a very strict stance and requires us to have full SW identifier in the DoC. Their basis was that MDR requires "unambiguous reference allowing identification and traceability". Therefore, we write all three digits in the DoC from now on. 

Hello RAPS Community,

If software versioning scheme is as follow: X.Y.Z where, X= major release, Y=low frequency updates (minor), Z= high frequency updates e.g. bugfixes; does a manufacturer of class I MD software should prepare the DoC for each software version e.g. 3 (X), 3.1 (X.Y) 3.1.1 (X.Y.Z)?

Same question regarding Letter to File: should letter to file be created for each above version independently?

Plus in any case there's need to include UDI:s (UDI-DI + UDI-PI) as part of technical documentation per MDR article 27(7) and MDCG 2021-19.

We use SW version as our UDI-PI.

I think they did not consider Basic UDI-DI adequate to distinquish between different software versions, as different versions can be placed on the market at the same time. Let's say 1.7.6 and 1.7.7 are on the market at the same time, the have the same basic UDI-DI, so how you differentiate between the two.

Something along that lines was their reasoning, and we decided not to challenge it as it's pretty easy to write a DoC.

Hi Hannes,

thanks for sharing that information.

Out of curiousity: Did the NB address how they interpret the next sentence of Annex IV (4) (where I think the "unambiguous" quote comes from) that states: "Except for the product or trade name, the information allowing identification and traceability may be provided by the Basic UDI-DI referred to in point 3."? Because referencing the Basic UDI-DI as a suitable unambiguous reference does not necessarily reflect the need to include a SW identifier down to the last digit.

Best regards, Christoph

Our NB took a very strict stance and requires us to have full SW identifier in the DoC. Their basis was that MDR requires "unambiguous reference allowing identification and traceability". Therefore, we write all three digits in the DoC from now on. 

Hello RAPS Community,

If software versioning scheme is as follow: X.Y.Z where, X= major release, Y=low frequency updates (minor), Z= high frequency updates e.g. bugfixes; does a manufacturer of class I MD software should prepare the DoC for each software version e.g. 3 (X), 3.1 (X.Y) 3.1.1 (X.Y.Z)?

Same question regarding Letter to File: should letter to file be created for each above version independently?