Exporting data to the cloud is a "Significant Change"?

yyoossssii

Starting to get Involved
#1
Dear all.

Exporting data from a class II MDD device to the cloud should be considered as a "Significant Change" that should evolve notified body (and new certification under MDR) ?

According to MDCG 2020-3 "Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD"

following chart C "SW change" of the Guidance there is no reason.
 
Last edited:
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Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#2
SECTION C – Design Changes and Changes of the Intended Purpose
Which may be Considered “Significant“ When Interpreting the First Sentence of MDR Art. 120(3)

New or major change of operating system or any
component?​
Yes - The change is considered Significant per MDR Art. 120(3) / No – See Question C2


New or modified architecture or database structure, change of an algorithm?
Yes - The change is considered Significant per MDR Art. 120(3) / No – See Question C3


Required user input replaced by closed loop algorithm ?
Yes - The change is considered Significant per MDR Art. 120(3) / No – See Question C4


New diagnostic or therapeutic feature, or new channel of interoperability?
Yes - The change is considered Significant per MDR Art. 120(3) / No – See Question C5


New user interface or presentation of data?
Yes - The change is considered Significant per MDR Art. 120(3) / No – See Question C6


Minor Change?
Yes - Return to Main Chart Question D / No – The change is considered Significant per MDR Art. 120(3)

 

yyoossssii

Starting to get Involved
#3
New diagnostic or therapeutic feature, or new channel of interoperability?
Yes - The change is considered Significant per MDR Art. 120(3) / No – See Question C5
exporting data should be considered as "interoperability"?
 

Raisin picker

Quite Involved in Discussions
#4
New or modified architecture or database structure, change of an algorithm?
You could exporting to the cloud consider a new/modified database structure as well. I'd say, either C2 or C4 applies. No matter which, NoC would be required, and in case of a legacy device, a MDR submission.
In any case, prepare a good reasoning, discuss this with your NB, and they might follow your argument. They will not provide any argument for "insignificant" for you, though.
 

yyoossssii

Starting to get Involved
#5
You could exporting to the cloud consider a new/modified database structure as well. I'd say, either C2 or C4 applies. No matter which, NoC would be required, and in case of a legacy device, a MDR submission.
In any case, prepare a good reasoning, discuss this with your NB, and they might follow your argument. They will not provide any argument for "insignificant" for you, though.
thanks
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#6
There are other options. If you include a risk based approach to the answers it could also help. Remember, you know your product better than the auditor/nb. If you provide well documented rationale as to why your answer is your answer it will be more challenging to refute it.
 
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