I have to second Richard, in the end you are not interested in the gap between the MDD and MDR for future compliance, but you are interested in the gap of your QMS, Technical Documentation, arrangements and contracts with the other Economic Operators and other documentation with the applicable requirements of the MDR.
Although there seems to be a common assumption that the MDR is a kind of a MDD+ (meaning that there are only new, additional and changed requirements and no contradictory requirements in the MDR) the changed structure makes it virtually impossible to do a 1-on-1 comparison of the requirements.
And as last argument, focussing on the gap between the MDD and MDR also assumes that your current documentation is completely MDD compliant and we all know that that is not always the case.....
So the best approach seems to be to read and understand the whole (..) thing and draw your conclusions. Your obtained MDR expertise will be valuable.
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Peter Reijntjes
Principal Consultant Regulatory & Quality Affairs
Arnhem
Netherlands
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Original Message:
Sent: 23-Jul-2019 18:14
From: Kimberly Parker Howard
Subject: Gap Analysis Between MDD and MDR
Hello, Anon---
I came across this on LinkedIn: https://www.regulatoryglobe.com/shop/mdr/mdd-vs-mdr-gap-assessment-tool/
There is a free version (you have to click the button, and it asks for some info) I can't vouch for this, but it was shared by some people that I admire.
Hopefully, it helps
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Kimberly Parker Howard
Ventura, CA
www.linkedin.com/in/kparkerhoward
Original Message:
Sent: 19-Jul-2019 00:03
From: Anonymous Member
Subject: Gap Analysis Between MDD and MDR
This message was posted by a user wishing to remain anonymous
Hello All,
Can you please share some of the most useful reference/guidance that you have found with regards to the differences between the MDD and MDR and those references/guidances that aid manufacturers in providing a gap analysis? A good example of the type of document I'm talking about is CEN/TR 17223:2018.
Thank you in advance!