Information regarding Nanomaterials in Medical Devices

T

TechnicalGuy

#1
Hi Covers,

Was hoping someone would be able to point me in the direction for information regarding nanomaterials in medical devices. What is the current legislation under the MDD? What is it in the MDR? What additional information is needed when a device incorporates a nanomaterial and where is this stated?

Are all devices incorporating nanomaterials upclassed to III? I heard a whisper of this.

Thanks
 
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dgrainger

Trusted Information Resource
#2
MDR rule 19:

All devices incorporating or consisting of nanomaterial are classified as:
— class III if they present a high or medium potential for internal exposure;
— class IIb if they present a low potential for internal exposure; and
— class IIa if they present a negligible potential for internal exposure.
 

moounir

Involved In Discussions
#3
Hi TechnicalGuy,

dgrainger is right. This depends on the exposure. So, it's not a whisper that nanomaterial will be taken into account but no products with nanomaterial are not specifically becoming class III.

I tried to make the same analysis regarding 3D Printing. I asked myself what is the impact on a product if the powder used is considered nanomaterial.

And it's true that if the material is in direct contact with the body, this can create some risks.
Check my review
 
T

TechnicalGuy

#4
Thanks guys. Much appreciated. I find this odd as there will be Class I medical devices which consist of powders which will of course contain some small % of their particle size in the nano range but to up-class this would be absurd.
 

dgrainger

Trusted Information Resource
#5
As defined in Article 2 (18-21):
(18) ‘nanomaterial’ means a natural, incidental or manufactured material containing particles in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm;​
Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm shall also be deemed to be nanomaterials;​
(19) ‘particle’, for the purposes of the definition of nanomaterial in point (18), means a minute piece of matter with defined physical boundaries;​
(20) ‘agglomerate’, for the purposes of the definition of nanomaterial in point (18), means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the​
individual components;​
(21) ‘aggregate’, for the purposes of the definition of nanomaterial in point (18), means a particle comprising of strongly bound or fused particles;​
 
#6
Is there one rule it makes differences between direct contact/no contact to the patient?
It is possible to say if my device has no contact to the patient than the classifcation remains?

Thanks
 

dgrainger

Trusted Information Resource
#7
Rule 19 applies whether there is contact or no contact. (unlike other rules that mention contact)
If there is nanomaterial in the device, class IIa is minimum classification.
 
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