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Annex II EU MDR gap analysis

#1
Dear All,
I’m working on a project regarding the compliance of the current technical documentation of an MD with the requirements of the MDR (reg. 745/2017). I was thinking to compare my documentation with Annexes II and III of the MDR and I was wondering if any of you have a gap analysis checklist versus these two Annexes or any other tips useful to carried out the job.

Thank you a lot!:)
 
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Mark Meer

Trusted Information Resource
#4
Hi ciccina,

I'd suggest that the regulation itself can serve as a pretty good checklist. Here's what I do:

  1. Copy-and-paste the text from Annex II into a text-editor (can be easily copy-and-pasted from the HTML version of the MDR).
  2. Now go through line by line making notes/comments under each documenting your findings (e.g. description of compliance state/strategy and/or references to documentation showing evidence of compliance). You might want to use a different font to distinguish the comments from the original MDR text.
  3. As you go through, adopt some font convention for assessment status. For example: green=covered, yellow=partial/uncertain, red=gap, grey=not applicable, normal/black=not assessed yet.

That's it! Once done (e.g. using the convention suggested above, once none of the original text is still black), you've got your gap analysis. The problem areas can be quickly identified by looking for any red or yellow text.

Just my simple, low-budget suggestion if you're the DIY type. ...but perhaps someone still has a fancy template to share! ;)
 
#5
Thank you a lot!!I have done something similar and I think will follow your suggestion about color scheme. I was thinking to add also annex III of the regulation because also this part should be integrated in the technical documentation of an MD, what do you think about?
 

Mark Meer

Trusted Information Resource
#6
...I was thinking to add also annex III of the regulation because also this part should be integrated in the technical documentation of an MD, what do you think about?
Certainly! Whatever requirements apply, you can follow the same approach - for example, I've also done it with the safety & performance requirements in Annex I, and the QSR requirements of FDA 21 CFR 820...

Your excel/spreadsheet-based approach is certainly much cleaner, and I'd considered it myself....it's just the first step (copying-and-pasting the requirements text) is more cumbersome, as you have to copy-and-paste each requirement individually.
...but, you end up with a template you can re-use for other projects or future gap analyses, so that bit of extra work could definitely be valuable.

Whatever works for you! Best of luck. :agree1:
MM.
 
R

ROHOLMES

#7
Hi ciccina,

I'd suggest that the regulation itself can serve as a pretty good checklist. Here's what I do:

  1. Copy-and-paste the text from Annex II into a text-editor
Thanks Mark, Can I ask why copy and paste from Annex II ? Sorry if this sounds like a daft question.
 

Mark Meer

Trusted Information Resource
#8
...Can I ask why copy and paste from Annex II ? Sorry if this sounds like a daft question.
Not a daft question at all, and to be honest I can't remember why I only mentioned Annex II. Really, anywhere where applicable requirements are specified - which includes many of the Annexes - should be used as source for any gap analysis checklist.
(pretty certain the focus on Annex II in this case was just because of the context of the thread discussion...)
Cheers!
 
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