Single Registration Number (SRN)

renenatasha

renenatasha

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#1
#1
Good day, Clover.
Hope everyone is doing fine in this trying time.

I've question in regards to SRN.
I'm working in a company that manufactures both MD and IVD.

I've applied for an SRN during MDR as the role of manufacturer but now that I'm working on IVDR, I'm not sure if current SRN is sufficient or will I need to apply for another SRN as a manufacturer for IVD.

Please share your thought. Thanks! :)
 
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ChrisM

ChrisM

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#2
#2
If it is the same company, my understanding is that there is only one SRN required; SRN is issued to a manufacturer ("actor" in European medical legislative terms) and does not depend on the types of products manufactured
 
renenatasha

renenatasha

Involved In Discussions
#3
#3
ChrisM said:
If it is the same company, my understanding is that there is only one SRN required; SRN is issued to a manufacturer ("actor" in European medical legislative terms) and does not depend on the types of products manufactured
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Thanks for sharing your view on this, Chris :)
 
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