Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello 

I would like to know if the nanomaterial assessment per EU MDR needs be exclusively performed to the raw material and coatings of the medical device or if the nanomaterial assessment needs to also be performed for each contact materials used during the manufacturing process.

Thanks, 

Anon,

Maybe all of the above and/or each one separately?  Nanomaterials is a area of medical device regulation which there is not much guidance or direction yet.  The answer to your question highly depends on the materials being used, the finished medical device, intended purpose of device, manufacturing process, and interaction of each of the materials.  An evaluation like this would need to have specific information, technical information, and use, so you might want to seek some expert advice where can discuss proprietary and/or specific information.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 16-Aug-2023 15:17
From: Anonymous Member
Subject: Nanomaterials EU MDR

This message was posted by a user wishing to remain anonymous

Hello 

I would like to know if the nanomaterial assessment per EU MDR needs be exclusively performed to the raw material and coatings of the medical device or if the nanomaterial assessment needs to also be performed for each contact materials used during the manufacturing process.

Thanks, 

Right now, there is no guidance available. In that case, we have to work with what is in the Regulation. Nanomaterial is mentioned 8 times: 6 times with regards to definitions, once in Annex I, section 10.6, concerning particles that can be released in the body, and Rule 19, regarding various risk classes for devices incorporating or consisting of nanomaterials. 

With that in mind, manufacturers must consider if the device or the production process of a device, may expose users to particles being released in the body. They should also look at the finished device and see if it is or incorporates a nanomaterial. I can see that there can be challenges if a device is made by using a nanomaterial (e.g. a coating on one of the tools) which is not fully removed. In case, these are only extremely small traces, it can be justified that Rule 19 is not applicable, but Annex I, Section 10.6 would still apply. In the case, those traces cannot be justified as non-relevant, Rule 19 must be applied. In the case there is negligible exposure, the device will classify as Class IIa according to this rule (other rules may result in higher risk classes). 

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Ronald Boumans
MDR Expert
Super PRRC
Netherlands
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Original Message:
Sent: 16-Aug-2023 15:17
From: Anonymous Member
Subject: Nanomaterials EU MDR

This message was posted by a user wishing to remain anonymous

Hello 

I would like to know if the nanomaterial assessment per EU MDR needs be exclusively performed to the raw material and coatings of the medical device or if the nanomaterial assessment needs to also be performed for each contact materials used during the manufacturing process.

Thanks, 

This message was posted by a user wishing to remain anonymous

Appreciate the help and thoroughness on your responses.

Original Message:
Sent: 19-Aug-2023 03:16
From: Ronald Boumans
Subject: Nanomaterials EU MDR

Right now, there is no guidance available. In that case, we have to work with what is in the Regulation. Nanomaterial is mentioned 8 times: 6 times with regards to definitions, once in Annex I, section 10.6, concerning particles that can be released in the body, and Rule 19, regarding various risk classes for devices incorporating or consisting of nanomaterials. 

With that in mind, manufacturers must consider if the device or the production process of a device, may expose users to particles being released in the body. They should also look at the finished device and see if it is or incorporates a nanomaterial. I can see that there can be challenges if a device is made by using a nanomaterial (e.g. a coating on one of the tools) which is not fully removed. In case, these are only extremely small traces, it can be justified that Rule 19 is not applicable, but Annex I, Section 10.6 would still apply. In the case, those traces cannot be justified as non-relevant, Rule 19 must be applied. In the case there is negligible exposure, the device will classify as Class IIa according to this rule (other rules may result in higher risk classes). 

------------------------------
Ronald Boumans
MDR Expert
Super PRRC
Netherlands

Original Message:
Sent: 16-Aug-2023 15:17
From: Anonymous Member
Subject: Nanomaterials EU MDR

This message was posted by a user wishing to remain anonymous

Hello 

I would like to know if the nanomaterial assessment per EU MDR needs be exclusively performed to the raw material and coatings of the medical device or if the nanomaterial assessment needs to also be performed for each contact materials used during the manufacturing process.

Thanks, 

Hello Anon, as Richard said: it depends. The risk with nanomaterials that the MDR seeks to manage is exposure of the patient to nanoparticles shedded by the device, so this is the risk to manage by starting with all relvant exposure scenarios. If the production process is such that the device will be delivered to the patient with lots of nanomaterials on it and is then implanted, this is a relevant risk. If the raw materials are such that they release nanoparticles over time, this is a risk to manage. Etc. I recommend taking a look at the SCENIHR Opinion on the Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices, which  addresses the use of nanomaterials in medical devices and provides information for risk assessors regarding specific aspects that need to be considered in the safety evaluation of nanomaterials. That may give you some more context. And my book about the MDR and IVDR, The Enriched MDR and IVDR, discusses this and more nanomaterials related requirements in context.

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Erik Vollebregt
Partner
Amsterdam
Netherlands
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Original Message:
Sent: 16-Aug-2023 15:17
From: Anonymous Member
Subject: Nanomaterials EU MDR

This message was posted by a user wishing to remain anonymous

Hello 

I would like to know if the nanomaterial assessment per EU MDR needs be exclusively performed to the raw material and coatings of the medical device or if the nanomaterial assessment needs to also be performed for each contact materials used during the manufacturing process.

Thanks,