Non-significant changes

G

gabe2jadyn

Involved In Discussions
Good Morning:

We are just beginning the process of putting our MDR Technical Documentation together. We have a non-significant label change and wanted to know where in the Technical Documentation this would go? From what I have read with BSI, would this be included in the cover letter? Is there anywhere else? Thank you -

Gaylene
 
Ed Panek

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
How did you document the label changes are not significant? There is MDR guidance for that.
 
Doninina

Doninina

Registered
gabe2jadyn said:
Good Morning:

We are just beginning the process of putting our MDR Technical Documentation together. We have a non-significant label change and wanted to know where in the Technical Documentation this would go? From what I have read with BSI, would this be included in the cover letter? Is there anywhere else? Thank you -

Gaylene
Click to expand...
Hi , first of all you should do analysis in order if the change is significant or not according to MDCG 2020-3 . also you change inform your notify body about the changes and take their confirmation about the change , whether you can do this change or not . Also the latest version of your packaging should be added to the technical file.
 
Last edited:
D

Daliane101

Registered
When NB approves the non-significant change, what is the timeline to implement that change? This is not stated in 2020-03.
 
Orca1

Orca1

Involved In Discussions
For a non-significant label change in your MDR Technical Documentation, you should include the change in the relevant sections of the technical documentation as specified in MDR Annex II.

It is essential to record both the changes and the dates when the changes were made in a transparent manner. The manufacturer should be able to demonstrate that the changes do not affect the design or intended purpose of the device, based on the Declaration of Conformity and the corresponding technical documentation (MDCG 2020-2 rev.1, Page 5, Paragraph 1).

If the change requires approval from the notified body, you should inform the notified body of the planned changes, and they will assess whether a new conformity assessment is needed or if the changes can be addressed by means of a supplement to the EU technical documentation assessment certificate (MDR, ANNEX IX, CHAPTER II: 4.10).

It is not necessary to include the non-significant label change in the cover letter. However, you should ensure that the change is documented and traceable within the technical documentation.
 
R

raqaphantom

Registered
hi - a bit late to this thread but seems relevant to my question as well.

is there any guidance for manufacturers beyond 2020-3? specifically, for a product which has gone through MDR certification (Class IIb, to be specific) and now has changes made - which we believe are non-significant. all I see is for devices under MDD/AIMDD and the transition period - but nothing for devices already under MDR.

could use a bit of a sanity check here. obviously we'll be updating the Tech File and associated documentation....
 
E

EmiliaBedelia

Involved In Discussions
raqaphantom said:
hi - a bit late to this thread but seems relevant to my question as well.

is there any guidance for manufacturers beyond 2020-3? specifically, for a product which has gone through MDR certification (Class IIb, to be specific) and now has changes made - which we believe are non-significant. all I see is for devices under MDD/AIMDD and the transition period - but nothing for devices already under MDR.

could use a bit of a sanity check here. obviously we'll be updating the Tech File and associated documentation....
Click to expand...
As of now there is not updated guidance on significant changes under MDR specifically :( but here are the resources I personally reference - I would use all the information you have available to make a determination and write up a rationale based on that (whether you explicitly cite the guidance or not - I wouldn't cite 2014-3 for example, but I'd certainly read it and think about it).

1) Refer to the MDR itself- there are a few paragraphs that reference changes to the technical documentation.
2) I'd still look at 2020-3 even though it isn't strictly applicable for devices that are already MDR compliant. If it IS a significant change per 2020-3, I don't think it would fly as a nonsignificant change.
3) Does your NB have a form or notification process that they have you use? For example, BSI has a change notification form with a checklist of different items that may or may not be impacted, and then you document the rationale.
4) Anecdotally.... staff from my NB have, unofficially, suggested that the old NBOG 2014-3 guidance is still a useful reference, even though it is technically for MDD. I can't say with certainty whether your NB will agree and there are certainly conflicting opinions on this, but it's something.

Personally my team was not sure what to do either in the absence of MDR guidance. My notified body has a "non significant change" form where you document the change and defend why it does not require a full significant change review so I submitted a lot of non significant change notifications (for class III implantables and class IIa active) and most of the time, my NB agreed with our interpretation and signed off. Again, this is all dependent on your NB and probably the level of interaction you have with them generally.
 
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