Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi,

Does anyone have experience with integrating a medical device app into a 3rd party system in EU (under MDD and/or MDR)?

Our company makes a medical device hardware that requires a software app to operate it. They must work together so they are CE marked together as a system (class IIa).
We are working with some partners that want to integrate our software app into their existing software, so their patients can use their software but directly get the information from our hardware device (instead of having to go to our app every time those patients want to get info from our hardware). Essentially our business partners will receive a closed module that they can add into their own application but they cannot see what's inside our module. The patients using their system will then be able to go into their regular app and one part of that app will just be our module. 
We don't know yet whether the branding on the module will still be ours or if our business partners will want to put their own branding on the software so it won't have our logo and details anymore.

Our software is cleared in the US and we know it is possible to do this in the US, but not sure how to CE mark this in EU?
Is the fact that we have a CE mark for our system enough?
Do our business partners need to get their own CE mark for the system with our module integrated? If they do then would they need access to our algorithm and other technical documentation in order to submit to their notified body? Or can they just show our CE mark to their notified body and that would be enough?
Does the software have to show our logo, our details and our CE mark?
Are there different requirements for this under MDD and MDR?

Thank you for any advice you can give!

Good evening,

reading your sentences, my understanding is, that the integration of  your software app into their existing software (very likely) leads to a new medical device software, that is expected to be CE-certified against the MDR. I would do two things first: 
1. I would check if the planned new software remains in the class IIa. or has to be reclassified. The MDCG 2019-11 Guideline may provide the required information. (Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR ).
2. I would evaluate the currently available technical documentation of the planned new software according to the content of the MDCG 2020-1 (Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software). This may help you to judge the extent of the foreseen activities.

regards

------------------------------
Peter Mikó M.D
ArtPharm Ltd.
Gyermely
Hungary
------------------------------

Original Message:
Sent: 05-Dec-2020 21:43
From: Anonymous Member
Subject: Med Device Software Integration with 3rd Party Systems

This message was posted by a user wishing to remain anonymous

Hi,

Does anyone have experience with integrating a medical device app into a 3rd party system in EU (under MDD and/or MDR)?

Our company makes a medical device hardware that requires a software app to operate it. They must work together so they are CE marked together as a system (class IIa).
We are working with some partners that want to integrate our software app into their existing software, so their patients can use their software but directly get the information from our hardware device (instead of having to go to our app every time those patients want to get info from our hardware). Essentially our business partners will receive a closed module that they can add into their own application but they cannot see what's inside our module. The patients using their system will then be able to go into their regular app and one part of that app will just be our module.
We don't know yet whether the branding on the module will still be ours or if our business partners will want to put their own branding on the software so it won't have our logo and details anymore.

Our software is cleared in the US and we know it is possible to do this in the US, but not sure how to CE mark this in EU?
Is the fact that we have a CE mark for our system enough?
Do our business partners need to get their own CE mark for the system with our module integrated? If they do then would they need access to our algorithm and other technical documentation in order to submit to their notified body? Or can they just show our CE mark to their notified body and that would be enough?
Does the software have to show our logo, our details and our CE mark?
Are there different requirements for this under MDD and MDR?

Thank you for any advice you can give!

Hello,

The simple answer is yes, you could indeed CE Mark your product in the European Union as a software app or as a stand alone software (SaMD).  However, there are many intricate complexities for how this could be done between selling as a system, selling as an add-on, selling separate which are intended to work together, which is probably a bit beyond the length of a forum post.  My suggestion is you need to develop a regulatory strategy for how this would be done and answering your questions may require a bit more external assistance.  There are different scenarios you could place your app and their hardware on the market, with different pathways for compliance which would need to go through each of them to determine which would fit your market model in the end.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 07-Dec-2020 12:43
From: Peter Miko
Subject: Med Device Software Integration with 3rd Party Systems

Good evening,

reading your sentences, my understanding is, that the integration of  your software app into their existing software (very likely) leads to a new medical device software, that is expected to be CE-certified against the MDR. I would do two things first:
1. I would check if the planned new software remains in the class IIa. or has to be reclassified. The MDCG 2019-11 Guideline may provide the required information. (Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR ).
2. I would evaluate the currently available technical documentation of the planned new software according to the content of the MDCG 2020-1 (Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software). This may help you to judge the extent of the foreseen activities.

regards

------------------------------
Peter Mikó M.D
ArtPharm Ltd.
Gyermely
Hungary

Original Message:
Sent: 05-Dec-2020 21:43
From: Anonymous Member
Subject: Med Device Software Integration with 3rd Party Systems

This message was posted by a user wishing to remain anonymous

Hi,

Does anyone have experience with integrating a medical device app into a 3rd party system in EU (under MDD and/or MDR)?

Our company makes a medical device hardware that requires a software app to operate it. They must work together so they are CE marked together as a system (class IIa).
We are working with some partners that want to integrate our software app into their existing software, so their patients can use their software but directly get the information from our hardware device (instead of having to go to our app every time those patients want to get info from our hardware). Essentially our business partners will receive a closed module that they can add into their own application but they cannot see what's inside our module. The patients using their system will then be able to go into their regular app and one part of that app will just be our module.
We don't know yet whether the branding on the module will still be ours or if our business partners will want to put their own branding on the software so it won't have our logo and details anymore.

Our software is cleared in the US and we know it is possible to do this in the US, but not sure how to CE mark this in EU?
Is the fact that we have a CE mark for our system enough?
Do our business partners need to get their own CE mark for the system with our module integrated? If they do then would they need access to our algorithm and other technical documentation in order to submit to their notified body? Or can they just show our CE mark to their notified body and that would be enough?
Does the software have to show our logo, our details and our CE mark?
Are there different requirements for this under MDD and MDR?

Thank you for any advice you can give!

Hi,

just one more note. Till now none of the stakeholders paid much attention to the CE-certification of software as medical device in the EU. On the web there are medical device software without any CE-mark. There is no established practice, how these matters are expected to be managed. The guidelines MEDDEV 2.1/6 , MDCG 2019-11 and 2020-1 are useful tools, that are expected to be followed by all involved parties.

regards

------------------------------
Peter Mikó M.D
ArtPharm Ltd.
Gyermely
Hungary
------------------------------

Original Message:
Sent: 08-Dec-2020 04:27
From: Richard Vincins
Subject: Med Device Software Integration with 3rd Party Systems

Hello,

The simple answer is yes, you could indeed CE Mark your product in the European Union as a software app or as a stand alone software (SaMD).  However, there are many intricate complexities for how this could be done between selling as a system, selling as an add-on, selling separate which are intended to work together, which is probably a bit beyond the length of a forum post.  My suggestion is you need to develop a regulatory strategy for how this would be done and answering your questions may require a bit more external assistance.  There are different scenarios you could place your app and their hardware on the market, with different pathways for compliance which would need to go through each of them to determine which would fit your market model in the end.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 07-Dec-2020 12:43
From: Peter Miko
Subject: Med Device Software Integration with 3rd Party Systems

Good evening,

reading your sentences, my understanding is, that the integration of  your software app into their existing software (very likely) leads to a new medical device software, that is expected to be CE-certified against the MDR. I would do two things first:
1. I would check if the planned new software remains in the class IIa. or has to be reclassified. The MDCG 2019-11 Guideline may provide the required information. (Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR ).
2. I would evaluate the currently available technical documentation of the planned new software according to the content of the MDCG 2020-1 (Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software). This may help you to judge the extent of the foreseen activities.

regards

------------------------------
Peter Mikó M.D
ArtPharm Ltd.
Gyermely
Hungary

Original Message:
Sent: 05-Dec-2020 21:43
From: Anonymous Member
Subject: Med Device Software Integration with 3rd Party Systems

This message was posted by a user wishing to remain anonymous

Hi,

Does anyone have experience with integrating a medical device app into a 3rd party system in EU (under MDD and/or MDR)?

Our company makes a medical device hardware that requires a software app to operate it. They must work together so they are CE marked together as a system (class IIa).
We are working with some partners that want to integrate our software app into their existing software, so their patients can use their software but directly get the information from our hardware device (instead of having to go to our app every time those patients want to get info from our hardware). Essentially our business partners will receive a closed module that they can add into their own application but they cannot see what's inside our module. The patients using their system will then be able to go into their regular app and one part of that app will just be our module.
We don't know yet whether the branding on the module will still be ours or if our business partners will want to put their own branding on the software so it won't have our logo and details anymore.

Our software is cleared in the US and we know it is possible to do this in the US, but not sure how to CE mark this in EU?
Is the fact that we have a CE mark for our system enough?
Do our business partners need to get their own CE mark for the system with our module integrated? If they do then would they need access to our algorithm and other technical documentation in order to submit to their notified body? Or can they just show our CE mark to their notified body and that would be enough?
Does the software have to show our logo, our details and our CE mark?
Are there different requirements for this under MDD and MDR?

Thank you for any advice you can give!

Hi,

If I understand your explanation correctly, I do agree with Richard and Peter that multiple scenarios are possible. As I mainly work with and for companies producing Software as a Medical Device in EU I would suggest the following:

Investigate whether an API connection is possible to communicate the information from your application to the their software. With this I mean that you create a 'see-through' in their software for the patient to see the information as communicated by your application. This will allow the patient to still use only one (web or mobile) application but still see the information from multiple 'attached' medical devices. The software of your partner then can potentially qualify as a communication platform and not a medical device. This might make scaling up to more partners that wish to integrate your product more feasible. 

The flowchart provided in the MDCG guideline as mentioned by Peter might help you in this. 

Hope this helps. 

Kind regards,

------------------------------
Annemieke Eikelenboom
Legal Consultant
Nieuwerkerk aan den IJssel
Netherlands
------------------------------

Original Message:
Sent: 05-Dec-2020 21:43
From: Anonymous Member
Subject: Med Device Software Integration with 3rd Party Systems

This message was posted by a user wishing to remain anonymous

Hi,

Does anyone have experience with integrating a medical device app into a 3rd party system in EU (under MDD and/or MDR)?

Our company makes a medical device hardware that requires a software app to operate it. They must work together so they are CE marked together as a system (class IIa).
We are working with some partners that want to integrate our software app into their existing software, so their patients can use their software but directly get the information from our hardware device (instead of having to go to our app every time those patients want to get info from our hardware). Essentially our business partners will receive a closed module that they can add into their own application but they cannot see what's inside our module. The patients using their system will then be able to go into their regular app and one part of that app will just be our module.
We don't know yet whether the branding on the module will still be ours or if our business partners will want to put their own branding on the software so it won't have our logo and details anymore.

Our software is cleared in the US and we know it is possible to do this in the US, but not sure how to CE mark this in EU?
Is the fact that we have a CE mark for our system enough?
Do our business partners need to get their own CE mark for the system with our module integrated? If they do then would they need access to our algorithm and other technical documentation in order to submit to their notified body? Or can they just show our CE mark to their notified body and that would be enough?
Does the software have to show our logo, our details and our CE mark?
Are there different requirements for this under MDD and MDR?

Thank you for any advice you can give!