Checklist for MDD to MDR gap analysis

shimonv

Trusted Information Resource
#1
Hi Folks,
Has anyone seen. a Checklist for MDD to MDR gap analysis?
We are getting close to the transition time.

Thanks,
Shimon
 
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Mark Meer

Trusted Information Resource
#2
Quick bump.
I'm starting the process, and it would certainly be helpful if anyone can share/link-to a resource highlighting the deviations from MDD.
Current strategy is to go through MDR, and extract all applicable requirements and create a whole new checklist...but it is quickly apparent that there's a lot of overlap, and so any resource(s) to focus in on the differences would be very handy.

Unfortunately the "Correlation Table" in Annex XVII of the MDR is not very helpful, as it only seems to show what is removed from MDD, and even for the items where a correlation is listed, the wording between "correlated" clauses is often different, and there is no indication if such differences/modification are substantive or not.
 

Jean_B

Trusted Information Resource
#3
A start can be found in "
CEN/TR 17223:2018
Guidance on the relationship between EN ISO 13485:2016 (Medical devices. Quality management systems. Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation" with respect to QMS.
As for the rest. I've found it best to treat it as a clean break. Doing any kind of shortcut adoption based on similarity might cost more than you might save as some changes have implicit effects in other parts of the text and thus should be fully reviewed anyway. Substantive difference question is answered by the absence of grandfathering. It simply should be regarded as that different.
 

Rincewind

Involved In Discussions
#5
A start can be found in "
CEN/TR 17223:2018
Guidance on the relationship between EN ISO 13485:2016 (Medical devices. Quality management systems. Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation" with respect to QMS.
As for the rest. I've found it best to treat it as a clean break. Doing any kind of shortcut adoption based on similarity might cost more than you might save as some changes have implicit effects in other parts of the text and thus should be fully reviewed anyway. Substantive difference question is answered by the absence of grandfathering. It simply should be regarded as that different.
Almost 400€...
 

Ellison

Starting to get Involved
#6
BSI had a decent whitepaper regarding the GSPR and how it correlated back to the ER if a correlation existed. It’s obviosuly not going to cover everything but it will help. We used it as additional guidance for the engineers who were performing the gap assessment to product.
 

shimonv

Trusted Information Resource
#9
Hi Fellows,
I just finished my first MDR gap assessment. Truly the best resource is BSI Transition to MDR page.
Specifically, I recommend the following:
1. MDR Readiness Review - this is a nice sanity check for MDR readiness.
2. How to prepare for and implement the upcoming MDR - Dos and Don'ts - this has a more comprehensive review of each chapter in the MDR and what to pay attention to.
3. MDR: Effects on QM-System - this is a nice presentation from confinis.com. What I like about it is the table showing the Articles/Annex number, whats it about, whats need to be done, and the how.

I believe these resources together with the MDR iteslf are sufficient to get going.

Cheers,
Shimon
 

Attachments

Ellison

Starting to get Involved
#10
Do you by chance have a link to it (I assume it's on a BSI website)?
The site wont let me link the site because I don't have enough posts :confused: but you assume correctly its on the BSI website. I recommend searching BSI Compliance Navigator white papers.
 
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