Regulatory Open Forum

Hello RAPS community,

As we finalize our internal SOP for managing changes post-DoA (for MDD-certified devices), I'm having some trouble interpreting the MDCG 2020-3 guidance. 

This guidance categorizes changes as "significant according to Article 120" or "non-significant according to Article 120". It obviously does not give details of how "non-significant changes" will be handled by notified bodies, but our current interpretation for our own NB is that such changes will likely need to be submitted and approved/agreed upon as non-significant, similar to what we would now classify as a significant change. (And of course changes classified as "significant" are just not possible until full transition to MDR.) 

The guidance doesn't do a great job (IMO) of talking about what we would currently call non-significant changes – i.e., those that don't need any submission at all, and can be implemented within our quality system as an internal documentation change. The only information I see about this is in the first few paragraphs of Section 4 of the guidance, but I find it very difficult to interpret. 

What I'm mainly trying to understand is this: if you only follow the flowcharts, everything will come out as either "significant" (i.e., not possible) or "non-significant" (which we interpret to require a submission). There are no paths that point to "internal documentation". I assume in the absence of any specific guidance from our NB, we will need to create another flowchart that details our internal assumptions about what would fall into this internal documentation category. Is anyone aware of any additional guidance to help here? Or am I missing something very obvious in this guidance?

I'd be very grateful for any help from this community of experts!

Hello

NB-MED/2.5.2/Rec2 is still useful in this context. It offers some guidance on developing the internal procedure for assessing the significance of changes.

https://www.team-nb.org/wp-content/uploads/2015/05/documents2012andolders/R2_5_2-2_rev7.pdf

​

Hello RAPS community,

As we finalize our internal SOP for managing changes post-DoA (for MDD-certified devices), I'm having some trouble interpreting the MDCG 2020-3 guidance. 

This guidance categorizes changes as "significant according to Article 120" or "non-significant according to Article 120". It obviously does not give details of how "non-significant changes" will be handled by notified bodies, but our current interpretation for our own NB is that such changes will likely need to be submitted and approved/agreed upon as non-significant, similar to what we would now classify as a significant change. (And of course changes classified as "significant" are just not possible until full transition to MDR.) 

The guidance doesn't do a great job (IMO) of talking about what we would currently call non-significant changes – i.e., those that don't need any submission at all, and can be implemented within our quality system as an internal documentation change. The only information I see about this is in the first few paragraphs of Section 4 of the guidance, but I find it very difficult to interpret. 

What I'm mainly trying to understand is this: if you only follow the flowcharts, everything will come out as either "significant" (i.e., not possible) or "non-significant" (which we interpret to require a submission). There are no paths that point to "internal documentation". I assume in the absence of any specific guidance from our NB, we will need to create another flowchart that details our internal assumptions about what would fall into this internal documentation category. Is anyone aware of any additional guidance to help here? Or am I missing something very obvious in this guidance?

I'd be very grateful for any help from this community of experts!

Hello RAPS community,

As we finalize our internal SOP for managing changes post-DoA (for MDD-certified devices), I'm having some trouble interpreting the MDCG 2020-3 guidance. 

This guidance categorizes changes as "significant according to Article 120" or "non-significant according to Article 120". It obviously does not give details of how "non-significant changes" will be handled by notified bodies, but our current interpretation for our own NB is that such changes will likely need to be submitted and approved/agreed upon as non-significant, similar to what we would now classify as a significant change. (And of course changes classified as "significant" are just not possible until full transition to MDR.) 

The guidance doesn't do a great job (IMO) of talking about what we would currently call non-significant changes – i.e., those that don't need any submission at all, and can be implemented within our quality system as an internal documentation change. The only information I see about this is in the first few paragraphs of Section 4 of the guidance, but I find it very difficult to interpret. 

What I'm mainly trying to understand is this: if you only follow the flowcharts, everything will come out as either "significant" (i.e., not possible) or "non-significant" (which we interpret to require a submission). There are no paths that point to "internal documentation". I assume in the absence of any specific guidance from our NB, we will need to create another flowchart that details our internal assumptions about what would fall into this internal documentation category. Is anyone aware of any additional guidance to help here? Or am I missing something very obvious in this guidance?

I'd be very grateful for any help from this community of experts!

Hello RAPS community,

As we finalize our internal SOP for managing changes post-DoA (for MDD-certified devices), I'm having some trouble interpreting the MDCG 2020-3 guidance. 

This guidance categorizes changes as "significant according to Article 120" or "non-significant according to Article 120". It obviously does not give details of how "non-significant changes" will be handled by notified bodies, but our current interpretation for our own NB is that such changes will likely need to be submitted and approved/agreed upon as non-significant, similar to what we would now classify as a significant change. (And of course changes classified as "significant" are just not possible until full transition to MDR.) 

The guidance doesn't do a great job (IMO) of talking about what we would currently call non-significant changes – i.e., those that don't need any submission at all, and can be implemented within our quality system as an internal documentation change. The only information I see about this is in the first few paragraphs of Section 4 of the guidance, but I find it very difficult to interpret. 

What I'm mainly trying to understand is this: if you only follow the flowcharts, everything will come out as either "significant" (i.e., not possible) or "non-significant" (which we interpret to require a submission). There are no paths that point to "internal documentation". I assume in the absence of any specific guidance from our NB, we will need to create another flowchart that details our internal assumptions about what would fall into this internal documentation category. Is anyone aware of any additional guidance to help here? Or am I missing something very obvious in this guidance?

I'd be very grateful for any help from this community of experts!

Hello RAPS community,

As we finalize our internal SOP for managing changes post-DoA (for MDD-certified devices), I'm having some trouble interpreting the MDCG 2020-3 guidance. 

This guidance categorizes changes as "significant according to Article 120" or "non-significant according to Article 120". It obviously does not give details of how "non-significant changes" will be handled by notified bodies, but our current interpretation for our own NB is that such changes will likely need to be submitted and approved/agreed upon as non-significant, similar to what we would now classify as a significant change. (And of course changes classified as "significant" are just not possible until full transition to MDR.) 

The guidance doesn't do a great job (IMO) of talking about what we would currently call non-significant changes – i.e., those that don't need any submission at all, and can be implemented within our quality system as an internal documentation change. The only information I see about this is in the first few paragraphs of Section 4 of the guidance, but I find it very difficult to interpret. 

What I'm mainly trying to understand is this: if you only follow the flowcharts, everything will come out as either "significant" (i.e., not possible) or "non-significant" (which we interpret to require a submission). There are no paths that point to "internal documentation". I assume in the absence of any specific guidance from our NB, we will need to create another flowchart that details our internal assumptions about what would fall into this internal documentation category. Is anyone aware of any additional guidance to help here? Or am I missing something very obvious in this guidance?

I'd be very grateful for any help from this community of experts!