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EU MDR Safety & Performance Requirements vs. MDD ERs (June 2017)

Sam Lazzara

Trusted Information Resource
#1
I have begun my slow EU MDR digestion process by drafting a cross-reference between the MDR S&PRs versus the MDD ERs (Essential Requirements). You can access it here.

If you are interested in a MS Word version, click here.

I did my best to correlate the "old" Essential Requirements to the "new" Safety & Performance Requirements, but there is always a chance I screwed up. So please let me know if you see any problems, or see ways to improve it.
 
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MDRexpert

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#2
Hi Sam,

The link doesn't work anymore for Europe MDR 2017/745 General Req vs. MDD 93/42/EEC Essential Req. Can you please upload the document here? Thanks!
 
T

tox472

#3
Hi Sam,
Thanks for sharing. BSI has issued an interesting white paper on this subject, if it can help in consolidating.
«General Safety and Performance
Requirements (Annex I) in the New
Medical Device Regulation
Comparison with the Essential Requirements of the Medical
Device Directive and Active Implantable Device Directive»
Gaëlle
 

MDRexpert

Involved In Discussions
#4
Hi Sam,

The link doesn't work anymore for Europe MDR 2017/745 General Req vs. MDD 93/42/EEC Essential Req. Can you please upload the document here? Thanks!
Just wanted to mention that for some reason the document does not open in IE. I tried again in google chrome and was able to see it.

Thanks Sam!
 
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