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Why is upgrading from say Windows 7 to Windows 10 compatibility considered a significant change which would require NB notification? Even when you release a new product to the EU, you don't have to notify your NB unless the product is Class III. The NB will review the device at the next annual audit.
So when MDCG 2020-3 says a new or major change in operating system is a Significant Change, are we only talking about Article 120(3) which will require upgrading from MDD to MDR? Or are we only talking about Class III devices?
Original Message:
Sent: 31-May-2020 16:58
From: David Geraghty
Subject: Software-Significant Change
Richard,
Thank you for your input. I did review the earlier thread and they seemed to deal with other aspect of the decision flow. My question is specific to OS and Server changes.
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David Geraghty
Director QA & RA
Redmond WA
Original Message:
Sent: 30-May-2020 01:36
From: Richard Vincins
Subject: Software-Significant Change
Hello David,
From my perspective the short answer is yes. There was another thread on this subject a couple months ago if you search through the forums there is some additional thoughts and comments on this subject you might find interesting.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 29-May-2020 14:04
From: David Geraghty
Subject: Software-Significant Change
I would like to ask the group how others are implementing the EU MDR Article 120(3) and the MDCG Guidance, MDCG 2020-3 document when it comes to Software. The guidance flow chart, C1, says that a new or major change of operating system is considered significant change. The implication of documenting a significant change determination is that regulatory clearances; EU Notified Body, FDA, Health Canada, and the TGA; require notification and updated filings.
Have others treated updates to newer version of Microsoft Windows and SQL servers as significant and filed new clearances?
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David Geraghty
Director QA & RA
Redmond WA
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