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Authorized Rep (AR), competent authority, NCA and notified body - Differences

MDRexpert

Involved In Discussions
#1
Hi Everyone,

I am a little confused as to what the difference between these terms. People interchangeably use them and I just wanted to understand it.

Authorized Rep (AR) - Also known as Competent authority/ European representative?
Notified Body - Regulatory Body in EU - Certification organization.
National competent authority (NCA) - AR?

Please clarify- Also is NCA specifically for Drug? is it also applicable to medical devices?
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#2
Hi Everyone,

I am a little confused as to what the difference between these terms. People interchangeably use them and I just wanted to understand it.

Authorized Rep (AR) - Also known as Competent authority/ European representative?
Notified Body - Regulatory Body in EU - Certification organization.
National competent authority (NCA) - AR?

Please clarify- Also is NCA specifically for Drug? is it also applicable to medical devices?
Authorized representative - "Represents" the manufacturer from abroad in Europe.

National competent authority (NCA) - Medical device authority from each country (for example, MHRA in England).

Notified Body - body designated by an NCA to perform conformity assessment activities related to specific rules (in the case of MDD/MDR, the NBs are designated to perform the "routes" related to each class of device).
 

MDRexpert

Involved In Discussions
#3
Thanks Marcelo!
So, when you file a FSCA, do you work with AR or NCA?
And is NCA specifically an authority in UK?

I'm writing a SOP on FSCA and advisory notice. In the existing SOP, NCA is mentioned everywhere, but I believe it should be "AR" as they're representing us and will be performing the recall activity for us? Is that correct?
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#4
So, when you file a FSCA, do you work with AR or NCA?
Generally, both. If you are a manufacturer from abroad, and you have to perform a FSCA, you have to notify who NC of each country. The involvement of the AR is defined by what is required by them by the manufacturer (the AR only do what the manufacturer mandates them do).

And is NCA specifically an authority in UK?
Each country his one or more NCAs.

I'm writing a SOP on FSCA and advisory notice. In the existing SOP, NCA is mentioned everywhere, but I believe it should be "AR" as they're representing us and will be performing the recall activity for us? Is that correct?
Np idea what your SOP says, but recall and any other related FSCA are performed by the manufacturer, not the AR (unless your mandate/contract specifically says that they will do it on your behalf).
 

MDRexpert

Involved In Discussions
#5
So, on reporting a recall, how do you start a report and where do you send the FSCA?
I thought the "AR" would be the mediator to communicate the recall information.
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#8
not sure what you mean. Can you be specific?
Sure, see the attached example. You have too identify the specific regulatory requirement (such as the ones mentioned for the MDR), then you need to identify your target countries (including your RA country which will be "your country"), and then map, for each, the application of the related requirements.
 

Attachments

MDRexpert

Involved In Discussions
#9
Thanks Marcelo!
We are a contract manufacturer so we never had to file a FSCA. But with our new product being registered we may have to do that in future.
Currently, we have Emergo as our "AR: and BSI as our notified body, but it is confusing to write the procedure details since I am not clear who should we communicate in case of FSCA. Also, EUDAMED is MDR requirements, our product will be MDD compliant by the end of the year. Does that mean we have to update the EUDAMED details to our procedure?
 

MDRexpert

Involved In Discussions
#10
Just went through the MEDDEV guidelines. To clarify for someone that is confused like me.

The manufacturer reports or his authorized rep notify the relevant National competent authority where the incident occurred.
Its the manufacturer's responsibility to do the investigation and CA. Manufacturer must keep the notified body advised of issues occurring the post production phase affecting the certification.

https://regulatorydoctor.us/wp-cont...nes-on-a-medical-devices-vigilance-system.pdf
 
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