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Regulation Approach on Mobile Application which is Medical Device Acccesory

D

dakrawat

#1
#1
I want to regulate a mobile application which is an accesory to already existed medical device so what should i include in my regulation study.?
What are the regulatory bodies should i include?? What are the new Guidance documents ?? As i have seen medical device documents on europa website. And they are dated april 1993 respectively (uploaded with this post ). So are ther any new guidance documents on medical device and what should be my approach for the documentation??
Thankz in advance
 

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sagai

sagai

Quite Involved in Discussions
#2
#2
Welcome to the Cove!

So, I assume that you are only considering EU legislation.
The directive itself is here with all amendments:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31993L0042:en:NOT

The guidance is published here:
http://ec.europa.eu/health/medical-devices/documents/guidelines/

what should i include in my regulation study.?
Click to expand...
Quite frankly I do not know, it is up to you. What do refer to as "regulation study"?

What are the regulatory bodies should i include??
Click to expand...
I think I would ask you to elaborate this question, for me it is difficult to really interpret properly for myself.

What are the new Guidance documents ??
Click to expand...
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31993L0042:en:NOT

they are dated april 1993 respectively
Click to expand...
Do not worry about it, they are amended on a regular basis, when you click on the latest revision, you got the latest and greatest version.

So are ther any new guidance documents on medical device and what should be my approach for the documentation??
Click to expand...
Well, that is in the MDD, see my first link.
There is a notified body kind of guidance for the technical file here:
http://www.team-nb.org/documents/20...MED-R2_5_1-5_rev4_Technical_Documentation.pdf
however it is solely recommendation.

Hope it helps.
Cheers!
 
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