Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello Regulatory Community 

I have two questions with regards to the EU MDR. 

Chapter 2, Article 12 - Change of Authorized Representative 

(b) the date until which the outgoing authorised representative may be indicated in the information supplied by the manufacturer, including any promotional material;

Question 1: In relation to the above, is there any requirement for the AR information to be on the promotional material? We got dinged by an auditor once during an MDD audit for not having the CE symbol on our promotional material which we have added since, but I'm not clear on whether we also need AR information to be on there. It doesn't appear like it's a mandatory requirement but perhaps that's how I am interpreting it. 

Question 2: Unrelated to the above, we are in the process of scheduling our EU MDR audit and our NB is adamant about doing it on-site despite the new statement from the European Commission on this. We are currently in a total lockdown with everyone working remotely. The auditor will be flying in from a different location. We have been trying to push back on this but they are being very persistent. Has anyone else encountered similar challenges with scheduling these audits? 

Thanks in advance for your time.

Regarding your second question – there was a great post from Erik Vollebregt last week about the new EC notice on remote audits. The bottom line is that the EC has left it up to individual member states to determine whether remote audits are acceptable. Perhaps your NB is located in a country that is not supportive of remote audits? 

Jennifer

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Jennifer Cabralda, RAC (US, CAN)
Director, Regulatory Affairs
Richmond, BC, Canada
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Original Message:
Sent: 26-Jan-2021 17:57
From: Anonymous Member
Subject: EU MDR + Audit

This message was posted by a user wishing to remain anonymous

Hello Regulatory Community

I have two questions with regards to the EU MDR.

Chapter 2, Article 12 - Change of Authorized Representative

(b) the date until which the outgoing authorised representative may be indicated in the information supplied by the manufacturer, including any promotional material;

Question 1: In relation to the above, is there any requirement for the AR information to be on the promotional material? We got dinged by an auditor once during an MDD audit for not having the CE symbol on our promotional material which we have added since, but I'm not clear on whether we also need AR information to be on there. It doesn't appear like it's a mandatory requirement but perhaps that's how I am interpreting it.

Question 2: Unrelated to the above, we are in the process of scheduling our EU MDR audit and our NB is adamant about doing it on-site despite the new statement from the European Commission on this. We are currently in a total lockdown with everyone working remotely. The auditor will be flying in from a different location. We have been trying to push back on this but they are being very persistent. Has anyone else encountered similar challenges with scheduling these audits?

Thanks in advance for your time.

Good morning,

my understanding is, that the AR is the legally responsible entity, that represents the non-EU manufacturer. The appropriateness of the devices' promotional materials is the legal responsibility of the manufacturer. As the manufacturer is  not located in the EU, the AR is responsible for the compliance with the applicable laws (EU+national). Therefore, I think, the AR should appear on the promotional materials.

regards


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Peter Mikó M.D
ArtPharm Ltd.
Gyermely
Hungary
------------------------------

Original Message:
Sent: 27-Jan-2021 15:29
From: Jennifer Cabralda
Subject: EU MDR + Audit

Regarding your second question – there was a great post from Erik Vollebregt last week about the new EC notice on remote audits. The bottom line is that the EC has left it up to individual member states to determine whether remote audits are acceptable. Perhaps your NB is located in a country that is not supportive of remote audits?

Jennifer

------------------------------
Jennifer Cabralda, RAC (US, CAN)
Director, Regulatory Affairs
Richmond, BC, Canada

Original Message:
Sent: 26-Jan-2021 17:57
From: Anonymous Member
Subject: EU MDR + Audit

This message was posted by a user wishing to remain anonymous

Hello Regulatory Community

I have two questions with regards to the EU MDR.

Chapter 2, Article 12 - Change of Authorized Representative

(b) the date until which the outgoing authorised representative may be indicated in the information supplied by the manufacturer, including any promotional material;

Question 1: In relation to the above, is there any requirement for the AR information to be on the promotional material? We got dinged by an auditor once during an MDD audit for not having the CE symbol on our promotional material which we have added since, but I'm not clear on whether we also need AR information to be on there. It doesn't appear like it's a mandatory requirement but perhaps that's how I am interpreting it.

Question 2: Unrelated to the above, we are in the process of scheduling our EU MDR audit and our NB is adamant about doing it on-site despite the new statement from the European Commission on this. We are currently in a total lockdown with everyone working remotely. The auditor will be flying in from a different location. We have been trying to push back on this but they are being very persistent. Has anyone else encountered similar challenges with scheduling these audits?

Thanks in advance for your time.