Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

I'm hoping that some of you have EU MDR experience with non-invasive, non-sterile, low risk devices incorporating nano-particles and can help me with this question:

How would you classify the following device under the EU MDR:

• Sport garments (e.g. tubular, elastic knee/elbow/leg sleeve intended to be worn externally on a limb) infused with carbon and/or germanium that are stimulated by body heat to increase circulation.
• Previously MDD Class I (Rule 1, non-invasive, non-sterile, intended to contact intact skin only)

So far, we've found that these resources:

• SCENIHR Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices 
• BSI presentation "Nanomaterials and medical device regulations"

are helpful in confirming that released nano-sized components have a low potential to penetrate through the skin (which is good-->risk profile remains low). And we are currently trying to confirm the particle size of carbon and germanium in the fabric to see if they meet the MDR definition and size range for nanomaterial (1-100nm). However, if they do, it still seems overkill to classify these "everyday" devices as Class IIa, per Rule 19.

Has someone used or would use a justification/rationale to keep these devices in Class I? Any thoughts are welcome! Thank you for your help.

This message was posted by a user wishing to remain anonymous

Hi - I have a similar question relating to one of our products. Since we don't have an existing relationship with a NB (Class I under the MDD), we cannot go to them to confirm the classification. I look forward to hearing what other regulatory professionals have to say. Cheers
Original Message:
Sent: 16-Jul-2020 01:52
From: Anonymous Member
Subject: EU MDR: Nanoparticle (Rule 19) - Non-invasive, intact skin only devices (

This message was posted by a user wishing to remain anonymous

I'm hoping that some of you have EU MDR experience with non-invasive, non-sterile, low risk devices incorporating nano-particles and can help me with this question:

How would you classify the following device under the EU MDR:

• Sport garments (e.g. tubular, elastic knee/elbow/leg sleeve intended to be worn externally on a limb) infused with carbon and/or germanium that are stimulated by body heat to increase circulation.
• Previously MDD Class I (Rule 1, non-invasive, non-sterile, intended to contact intact skin only)

So far, we've found that these resources:

• SCENIHR Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices 
• BSI presentation "Nanomaterials and medical device regulations"

are helpful in confirming that released nano-sized components have a low potential to penetrate through the skin (which is good-->risk profile remains low). And we are currently trying to confirm the particle size of carbon and germanium in the fabric to see if they meet the MDR definition and size range for nanomaterial (1-100nm). However, if they do, it still seems overkill to classify these "everyday" devices as Class IIa, per Rule 19.

Has someone used or would use a justification/rationale to keep these devices in Class I? Any thoughts are welcome! Thank you for your help.

Hi Anon,


If your product is considered a Medical Device from a NB, then I do not see any alternative from going with Rule 19.
If one or more external dimensions is in the size range 1-100 nm; for 50 % or more of the particles in the number size distribution, then they are considered nanoparticles. Of course for non-invasive devices the toxicological risk assessment will not be as much detailed.

Hope that helps

------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece
------------------------------

Original Message:
Sent: 16-Jul-2020 01:52
From: Anonymous Member
Subject: EU MDR: Nanoparticle (Rule 19) - Non-invasive, intact skin only devices (

This message was posted by a user wishing to remain anonymous

I'm hoping that some of you have EU MDR experience with non-invasive, non-sterile, low risk devices incorporating nano-particles and can help me with this question:

How would you classify the following device under the EU MDR:

• Sport garments (e.g. tubular, elastic knee/elbow/leg sleeve intended to be worn externally on a limb) infused with carbon and/or germanium that are stimulated by body heat to increase circulation.
• Previously MDD Class I (Rule 1, non-invasive, non-sterile, intended to contact intact skin only)

So far, we've found that these resources:

• SCENIHR Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices 
• BSI presentation "Nanomaterials and medical device regulations"

are helpful in confirming that released nano-sized components have a low potential to penetrate through the skin (which is good-->risk profile remains low). And we are currently trying to confirm the particle size of carbon and germanium in the fabric to see if they meet the MDR definition and size range for nanomaterial (1-100nm). However, if they do, it still seems overkill to classify these "everyday" devices as Class IIa, per Rule 19.

Has someone used or would use a justification/rationale to keep these devices in Class I? Any thoughts are welcome! Thank you for your help.

The first task would be to verify that the product is indeed a device (a medical device, an accessories or Annex XVI product). With a class I it may be scrutinized at some point by an authority and for higher risk class before even the NB will quote the service. If you are outside the EU the EC REP may challenge it. Since it being stated that this product should be a medical device it may be beneficial to substantiate this with the definition given in Article 2.

The MDR may not apply at all and with that there would be no headache in regards to the classification of the MDR.
With the MDR the market will be cleared of certain products since manufacturers view their products now differently.

Please let me know whether the above information is helpful.

------------------------------
Ludger Moeller
President, MDSS GmbH
l.moeller@mdssar.com
------------------------------

Original Message:
Sent: 17-Jul-2020 03:19
From: Spyros Drivelos
Subject: EU MDR: Nanoparticle (Rule 19) - Non-invasive, intact skin only devices (

Hi Anon,


If your product is considered a Medical Device from a NB, then I do not see any alternative from going with Rule 19.
If one or more external dimensions is in the size range 1-100 nm; for 50 % or more of the particles in the number size distribution, then they are considered nanoparticles. Of course for non-invasive devices the toxicological risk assessment will not be as much detailed.

Hope that helps

------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece

Original Message:
Sent: 16-Jul-2020 01:52
From: Anonymous Member
Subject: EU MDR: Nanoparticle (Rule 19) - Non-invasive, intact skin only devices (

This message was posted by a user wishing to remain anonymous

I'm hoping that some of you have EU MDR experience with non-invasive, non-sterile, low risk devices incorporating nano-particles and can help me with this question:

How would you classify the following device under the EU MDR:

• Sport garments (e.g. tubular, elastic knee/elbow/leg sleeve intended to be worn externally on a limb) infused with carbon and/or germanium that are stimulated by body heat to increase circulation.
• Previously MDD Class I (Rule 1, non-invasive, non-sterile, intended to contact intact skin only)

So far, we've found that these resources:

• SCENIHR Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices 
• BSI presentation "Nanomaterials and medical device regulations"

are helpful in confirming that released nano-sized components have a low potential to penetrate through the skin (which is good-->risk profile remains low). And we are currently trying to confirm the particle size of carbon and germanium in the fabric to see if they meet the MDR definition and size range for nanomaterial (1-100nm). However, if they do, it still seems overkill to classify these "everyday" devices as Class IIa, per Rule 19.

Has someone used or would use a justification/rationale to keep these devices in Class I? Any thoughts are welcome! Thank you for your help.