Essential Requirements Checklist for MDD 2007/47

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R

Roland Cooke

#5
I have seen hundreds of these (completed) checklists over the years, and to be honest, the vast majority of them have been a waste of time. They usually don't answer the question, and they usually don't allow me to find the supporting documentation, or at least not all of it, easily.

So while there is nothing wrong with the template, do make sure you use it properly.

What I tend to recommend, if you want to go the extra mile, is to turn the whole thing 90 degrees, so that there is proper space for a detailed response to each ER.

a) justification of non-applicability
b) confirmation of which general harmonised standards are applicable, and if not met in full, justifications for non-applicability of the sections or the whole standard (EN13485, EN14971, EN10993-1, EN980, EN1041 etc)
c) confirmation of which product-specific harmonised standards are applicable, and if not met in full, justifications for non-applicability of the sections or the whole standard
d) Short description (text) of how all the elements of the individual ER have been addressed met, if not already covered above
e) Location of supporting documentation held within the Technical File
f) Location of supporting documentation not held within the Technical File
 
S

Sintolt

#8
There seems to be a new requirement under 7.1:

"- where appropriate, the results of biophysical or modeling research whose validity has been demonstrated beforehand"

What sort of documents / tests can be refernenced here?
 
B

bobthom

#9
Ian, thanks for the document, o my checking it looks preety much close to the mark.

Regards,
Bob:thanx:
 
A

AC Cobra

#10
I had a few problems locating a word format template for an Essential Requirements Checklist which was compliant with MDD 93/42/EC as amended by 2007/47/EC.
After going blind by typing in such a small font size, here it is.
If anyone can see any mistakes, please let me know.

Thanks
Ian
:thanx: I've been looking for this checklist on the web and now I found it!! Thanks a lot! AC Cobra
 
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