EU MDR (GSPR Checklist) consolidated with TGA EP Checklist

medwise

Involved In Discussions
#1
Hi Experts,

Can someone please share a gap analysis or a consolidated EU MDR GSPR and TGA Essential Principles checklist?

Thank you.
medwise
 
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lahol

Registered
#5
Hi Experts,

Can someone please share a gap analysis or a consolidated EU MDR GSPR and TGA Essential Principles checklist?

Thank you.
medwise
Doing a gap analysis yourself should be pretty straightforward since both checklists are publicly available. I'd post links but unfortunately don't have enough posts to do so.

Otherwise I'm sure there are examples on the internet if you do a quick search.
 

RA_QA_Expert

Involved In Discussions
#6
Hi, TGA EP are similar to MDD ER. The base is GHTF document. If you did gap analysis between MDD ER a MDR GSPR, you can the results apply also for TGA EP.

The intention is still the same, to have product which is safe, effective and in regulatory compliance, but GSPR are more risk oriented and more specific. If you meet GSPR you yould be in compliance also with TGA EP (if country specific requirement are met).
 
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