Regulatory Open Forum

Dear RAPS members,

I would like to know what kind of software changes are considered significant under MDD and EU MDR.

Also i have a question regarding the guidance document MDCG 2020-03.
Flowchart C - Step C5 "presentation of data": if certain data (non-diagnostic features) was presented in the pictorial format in the previous software version is now displayed in a table format in the revised version will that fall under significant change?

Appreciate, if you can share your thoughts on this matter.

Thanks!

Regards,

------------------------------
Soumya Rajesh
Quality and Regulatory Affairs Manager
Den Haag
Netherlands
------------------------------

For your first question, recognize that any device can be in one of three states:
Full MDD
MDD as modified by EU-MDR Article 120
Full MDR

Under MDD and EU-MDR, the Notified Body determines when a change is a significant change. Typically, the NB includes it in the contract.

Under MDD as modified by EU-MDR Article 120 there is an MDCG guidance document that applies, 2020-03.

For software, there are two types. For software in a device, do not evaluate the software change, but its impact on the device. For software as a medical device, SaMD, evaluate the change at the device level (which is the software level).

For MDCG 2020-03 Flowchart C - Step C5 you first must decode the garbled data presented in the note. A new layout of the same data is a minor change. A new format of medical data is a significant change.

I believe that changing the form of non-diagnostic information from a pictorial format to a table format falls under the note's description of a minor change.

I recommend you also evaluate this change under the concepts of IEC 62366-1:2015, 4.1.3 to determine the key factors:
The user perceives the information
The user understands the information
The information supports correct use

The change in format may result in a new set of use errors.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------

Original Message:
Sent: 25-May-2020 05:34
From: Soumya Rajesh
Subject: Significant change assessment - Software

Dear RAPS members,

I would like to know what kind of software changes are considered significant under MDD and EU MDR.

Also i have a question regarding the guidance document MDCG 2020-03.
Flowchart C - Step C5 "presentation of data": if certain data (non-diagnostic features) was presented in the pictorial format in the previous software version is now displayed in a table format in the revised version will that fall under significant change?

Appreciate, if you can share your thoughts on this matter.

Thanks!

Regards,

------------------------------
Soumya Rajesh
Quality and Regulatory Affairs Manager
Den Haag
Netherlands
------------------------------

Thanks a lot Dan for the clear explanation! very much appreciated!

Kind Regards,

------------------------------
Soumya Rajesh
Quality and Regulatory Affairs Manager
Den Haag
Netherlands
------------------------------

Original Message:
Sent: 25-May-2020 09:57
From: Dan O'Leary
Subject: Significant change assessment - Software

For your first question, recognize that any device can be in one of three states:
Full MDD
MDD as modified by EU-MDR Article 120
Full MDR

Under MDD and EU-MDR, the Notified Body determines when a change is a significant change. Typically, the NB includes it in the contract.

Under MDD as modified by EU-MDR Article 120 there is an MDCG guidance document that applies, 2020-03.

For software, there are two types. For software in a device, do not evaluate the software change, but its impact on the device. For software as a medical device, SaMD, evaluate the change at the device level (which is the software level).

For MDCG 2020-03 Flowchart C - Step C5 you first must decode the garbled data presented in the note. A new layout of the same data is a minor change. A new format of medical data is a significant change.

I believe that changing the form of non-diagnostic information from a pictorial format to a table format falls under the note's description of a minor change.

I recommend you also evaluate this change under the concepts of IEC 62366-1:2015, 4.1.3 to determine the key factors:
The user perceives the information
The user understands the information
The information supports correct use

The change in format may result in a new set of use errors.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States

Original Message:
Sent: 25-May-2020 05:34
From: Soumya Rajesh
Subject: Significant change assessment - Software

Dear RAPS members,

I would like to know what kind of software changes are considered significant under MDD and EU MDR.

Also i have a question regarding the guidance document MDCG 2020-03.
Flowchart C - Step C5 "presentation of data": if certain data (non-diagnostic features) was presented in the pictorial format in the previous software version is now displayed in a table format in the revised version will that fall under significant change?

Appreciate, if you can share your thoughts on this matter.

Thanks!

Regards,

------------------------------
Soumya Rajesh
Quality and Regulatory Affairs Manager
Den Haag
Netherlands
------------------------------