Regulatory Open Forum

Dear All,

There is still time also I wish you all an excellent year 2022, with many constructive exchanges as always.

I have a new question, concerning the meaning of significant or substantial change under the European regulation 2017/746, to my knowledge there is no MDCG guide for the IVD.
Do you know a source of information on this subject?

Thanks for your answer

Kind Regards,

------------------------------
PASCALE
------------------------------

Pascale,

No there is not one specific to IVD medical devices, but many of the same concepts can be used ... with some thoughts specific to IVDs, e.g. changes in shelf-life/expiration date, change in antibody source, etc.  There is also the N-BOG document which has been referenced before, but again not specific to IVDs.  When we set up quality systems specifically change management, we create this "significant change" internally because it can also depend on the device type or quality system components.  In fact, when reviewing quality systems I recommend companies not to use the standard information from the guidance documents, but tailor them specific to the company as some may not apply and importantly there may be other aspects to be considered.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 19-Jan-2022 11:12
From: PASCALE BLANGARIN
Subject: Significant or substantial change under regulation 2017/746

Dear All,

There is still time also I wish you all an excellent year 2022, with many constructive exchanges as always.

I have a new question, concerning the meaning of significant or substantial change under the European regulation 2017/746, to my knowledge there is no MDCG guide for the IVD.
Do you know a source of information on this subject?

Thanks for your answer

Kind Regards,

------------------------------
PASCALE
------------------------------

Hello Richard,

Thanks a lot for your answer.

Kind Regards

------------------------------
PASCALE
------------------------------

Original Message:
Sent: 20-Jan-2022 02:54
From: Richard Vincins
Subject: Significant or substantial change under regulation 2017/746

Pascale,

No there is not one specific to IVD medical devices, but many of the same concepts can be used ... with some thoughts specific to IVDs, e.g. changes in shelf-life/expiration date, change in antibody source, etc.  There is also the N-BOG document which has been referenced before, but again not specific to IVDs.  When we set up quality systems specifically change management, we create this "significant change" internally because it can also depend on the device type or quality system components.  In fact, when reviewing quality systems I recommend companies not to use the standard information from the guidance documents, but tailor them specific to the company as some may not apply and importantly there may be other aspects to be considered.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 19-Jan-2022 11:12
From: PASCALE BLANGARIN
Subject: Significant or substantial change under regulation 2017/746

Dear All,

There is still time also I wish you all an excellent year 2022, with many constructive exchanges as always.

I have a new question, concerning the meaning of significant or substantial change under the European regulation 2017/746, to my knowledge there is no MDCG guide for the IVD.
Do you know a source of information on this subject?

Thanks for your answer

Kind Regards,

------------------------------
PASCALE
------------------------------

Hi Pascale,

There is indeed no MDCG also not for MDs on this topic. The expectation of some NB is to still use NBOG 2014-3 (Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System) for evaluating changes.

Hope this helps.

------------------------------
Ioana Ulea
Regulatory Affairs Professional
------------------------------

Original Message:
Sent: 19-Jan-2022 11:12
From: PASCALE BLANGARIN
Subject: Significant or substantial change under regulation 2017/746

Dear All,

There is still time also I wish you all an excellent year 2022, with many constructive exchanges as always.

I have a new question, concerning the meaning of significant or substantial change under the European regulation 2017/746, to my knowledge there is no MDCG guide for the IVD.
Do you know a source of information on this subject?

Thanks for your answer

Kind Regards,

------------------------------
PASCALE
------------------------------

Hi Ioana,

The use of the NBOG 2014-3 is certainly the most convenient for this topic today pending a specific IVD document according to the regulation 2017/746.

Thanks a lot for your answer

Kind Regards

------------------------------
PASCALE
------------------------------

Original Message:
Sent: 21-Jan-2022 07:50
From: Ioana Ulea
Subject: Significant or substantial change under regulation 2017/746

Hi Pascale,

There is indeed no MDCG also not for MDs on this topic. The expectation of some NB is to still use NBOG 2014-3 (Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System) for evaluating changes.

Hope this helps.

------------------------------
Ioana Ulea
Regulatory Affairs Professional

Original Message:
Sent: 19-Jan-2022 11:12
From: PASCALE BLANGARIN
Subject: Significant or substantial change under regulation 2017/746

Dear All,

There is still time also I wish you all an excellent year 2022, with many constructive exchanges as always.

I have a new question, concerning the meaning of significant or substantial change under the European regulation 2017/746, to my knowledge there is no MDCG guide for the IVD.
Do you know a source of information on this subject?

Thanks for your answer

Kind Regards,

------------------------------
PASCALE
------------------------------

Indeed, there is no MDCG guidance yet for either concept under the IVDR. Also, significant change and substantial change are two different legal concepts under the IVDR that are best not confused and certainly are not interchangable.
- Significant change is the design / intended purpose change that is not possible during the grace period under article 110 (3) IVDR, which becomes an important concept affecting many IVDs with the IVDR amendment proposal introducing grace periods under article 110 (3) for the majority of IVDs. Closest thing in guidance is MDCG 2020-3 on significant changes currently under the MDR only, which however gives you a good idea of what could be seen as substantial changes under the IVDR because there will be a lot of overlap (e.g. on software,, raw materials).
- Substantial change is the change that under the IVDD (and NBOG 2014-3) would be reportable to the NB and to be reviewed before implementation. At this time we cannot assume that this concept has been carried over from the IVDD 1-on-1 because Annex IX, section 4.11 1st para about device changes does not use the concept 'substantial change' but rather "Changes to the approved device […] where such changes could affect the safety and performance of the device or the conditions prescribed for use of the device" - this is not necessarily the exact same standard as in NBOG 2014-3 and I have seen notified bodies interpret it more broadly under the MDR (which uses the same standard).

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands
------------------------------

Original Message:
Sent: 19-Jan-2022 11:12
From: PASCALE BLANGARIN
Subject: Significant or substantial change under regulation 2017/746

Dear All,

There is still time also I wish you all an excellent year 2022, with many constructive exchanges as always.

I have a new question, concerning the meaning of significant or substantial change under the European regulation 2017/746, to my knowledge there is no MDCG guide for the IVD.
Do you know a source of information on this subject?

Thanks for your answer

Kind Regards,

------------------------------
PASCALE
------------------------------

Many thanks Erik for this explanation.

------------------------------
PASCALE
------------------------------

Original Message:
Sent: 22-Jan-2022 05:13
From: Erik Vollebregt
Subject: Significant or substantial change under regulation 2017/746

Indeed, there is no MDCG guidance yet for either concept under the IVDR. Also, significant change and substantial change are two different legal concepts under the IVDR that are best not confused and certainly are not interchangable.
- Significant change is the design / intended purpose change that is not possible during the grace period under article 110 (3) IVDR, which becomes an important concept affecting many IVDs with the IVDR amendment proposal introducing grace periods under article 110 (3) for the majority of IVDs. Closest thing in guidance is MDCG 2020-3 on significant changes currently under the MDR only, which however gives you a good idea of what could be seen as substantial changes under the IVDR because there will be a lot of overlap (e.g. on software,, raw materials).
- Substantial change is the change that under the IVDD (and NBOG 2014-3) would be reportable to the NB and to be reviewed before implementation. At this time we cannot assume that this concept has been carried over from the IVDD 1-on-1 because Annex IX, section 4.11 1st para about device changes does not use the concept 'substantial change' but rather "Changes to the approved device […] where such changes could affect the safety and performance of the device or the conditions prescribed for use of the device" - this is not necessarily the exact same standard as in NBOG 2014-3 and I have seen notified bodies interpret it more broadly under the MDR (which uses the same standard).

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands

Original Message:
Sent: 19-Jan-2022 11:12
From: PASCALE BLANGARIN
Subject: Significant or substantial change under regulation 2017/746

Dear All,

There is still time also I wish you all an excellent year 2022, with many constructive exchanges as always.

I have a new question, concerning the meaning of significant or substantial change under the European regulation 2017/746, to my knowledge there is no MDCG guide for the IVD.
Do you know a source of information on this subject?

Thanks for your answer

Kind Regards,

------------------------------
PASCALE
------------------------------

Dear Pascale

Unfortunately, there is alot left to be defined for IVD products.

Since things are so far behind with IVDs, I believe several of these MDCGs of medical devices will be adopted in part for IVD.  

There is MDCG guidance with regards to the definition of significant changes for medical devices certified under the MDD which may be helpful as a guide to make this determination for IVD products. See also the charts in the Annex.   

https://ec.europa.eu/docsroom/documents/40301?locale=en

Best Regards,
Stephanie

 

------------------------------
Stephanie Grassmann
Managing Director of MedTechXperts Ltd
Biberstein
Switzerland
------------------------------

Original Message:
Sent: 19-Jan-2022 11:12
From: PASCALE BLANGARIN
Subject: Significant or substantial change under regulation 2017/746

Dear All,

There is still time also I wish you all an excellent year 2022, with many constructive exchanges as always.

I have a new question, concerning the meaning of significant or substantial change under the European regulation 2017/746, to my knowledge there is no MDCG guide for the IVD.
Do you know a source of information on this subject?

Thanks for your answer

Kind Regards,

------------------------------
PASCALE
------------------------------