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For software change - New Channel of interoperability

#1
Dear all,

As the application date is coming closer and closer, I was reading the MDCG guidance related to substantial changes according to article 120 of the MDR.

For software change, it is mentioned that a new channel of interoperability is considered a substantial change.
Can someone here elaborate on what is considered a new channel of interoperability? Is it the implementation of a new standard (HL7, DICOM)? Or a new/updated API based on an already implemented standard is also substantial?

Thanks to anyone that can participate in this thread.
 
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yodon

Staff member
Super Moderator
#2
I did a couple of quick searches but didn't find anything. Can you post the URL (you may not be able to post the link so you may have to chop it up a bit).
 
#3
Dear Yodon,

Thank you for your reply.
The MDCG guidance is called: 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.
The link is the following: ec.europa.eu/docsroom/documents/40301/attachments/1/translations/en/renditions/native
And the mention of the "new channel of interoperability" is on page 10, in chart C.

I hope this helps.
Best.
 

yodon

Staff member
Super Moderator
#4
It does help, thank you! But I'm in the same boat with you now, not really knowing what they mean! My original thought was that it was maybe changing from, say, wired to wireless communications or maybe even to a different type of wireless (e.g., BLE to WiFi) but that would involve hardware so I don't think that's the intent. I think your initial thoughts are correct but could be both a new standard or a new/modified API.

Hopefully others will weigh in and have a more concrete answer.
 
#5
Dear Yodon,
Thank you for taking the time to look into it and provide your feedback.
Now let's hope that someone can shed the light on this mystery.
 
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