Location requirements of the PRRC for the EU MDR

fialor

Involved In Discussions
#1
Dear All,
Could anyone shed light on the location requirements of the PRRC for the EU MDR?
Like the EU Authorised Representative, must the PRRC be based in the EU?
Thanks
 
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chris1price

Trusted Information Resource
#2
Hi, Article 15 isn't very clear. However, the PRRC must be "within their organisation" which implies it can be outside of EU. Also, to have access to the necessary files in order to perform their responsibilities, they probably have to be based at the manufacturer's site. So I don't think the PRRC has to be based in EU.

Note, the Authorised Rep also has to have one person responsible for regulatory compliance.

Chris
 

fialor

Involved In Discussions
#3
Thanks Chris1price.

Yes - that is my understanding.
Clause 6 of article 15 advises the following:
"6. Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements for medical devices in the Union. The requisite expertise shall be demonstrated by either of the following qualifications: ... "

I have highlighted in the above text the area that I was looking for clarification/others' interpretation on. It reads to me that so long as the authorised rep has access to a PRRC there is no need for the PRRC to be based in the union.
I think that will continue to be my interpretation until an NB deems it fit to tell me otherwise. :D

Thank you for your response!
 

alag

Registered
#4
MDCG 2019-7 has been recently published by the EU commission. You can refer to that to some of the points discussed in previous messages
 
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