Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Has anybody used the voluntary consultation with an expert panel as per MDR Article 61(2) ? What has been the experience ? We have a device under development for which we are not sure of the classification and we assume it could be a class III, is there a way the expert advises on the classification and also provides an advice on the clinical pathway?

Hello Anon,

I would be interested too if someone has started to pursue this process.  We have not had any direct experience or reason to do this yet.  But I do understand it is a long and arduous process currently because there is no guidance or operating procedures defined for this process yet.  While the EU MDR article described what it is, there is no specifics on how this will be done.  Sorry I could not provide any specific information as not needed to pursue this regulatory status pathway yet.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 17-May-2023 07:52
From: Anonymous Member
Subject: Expert panel consultation - MDR

This message was posted by a user wishing to remain anonymous

Has anybody used the voluntary consultation with an expert panel as per MDR Article 61(2) ? What has been the experience ? We have a device under development for which we are not sure of the classification and we assume it could be a class III, is there a way the expert advises on the classification and also provides an advice on the clinical pathway?

You may already be aware, but the EMA is currently running a pilot to offer clinical development advice for high risk devices, which isn't exactly the same as what you are asking. I'm guessing this pilot would help inform other types of expert panel questions as well, but as it's so early in development, that may or may not be true.

https://www.ema.europa.eu/en/news/ema-pilots-scientific-advice-certain-high-risk-medical-devices

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Corey Jaseph RAC
Senior Research Analyst
Morongo Valley CA
United States
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Original Message:
Sent: 17-May-2023 07:52
From: Anonymous Member
Subject: Expert panel consultation - MDR

This message was posted by a user wishing to remain anonymous

Has anybody used the voluntary consultation with an expert panel as per MDR Article 61(2) ? What has been the experience ? We have a device under development for which we are not sure of the classification and we assume it could be a class III, is there a way the expert advises on the classification and also provides an advice on the clinical pathway?