Classification of device per Annex 8 of the EU MDR

[IZAKK]

Hi, I am looking for some guidance on Classification of device per Annex 8 of the EU MDR. Our devices are US Class 1, handpiece (saws and drill-reamers). Our main question is whether our device(s) are non-invasive or invasive. We believe our device is non-invasive as the handpiece device itself does not enter the body, only the applicable attachment accessory of saw blade, drill bit, etc. would be invasive and separately classified.

We came to this determination by review of the definition of a ‘Surgically invasive device’, which per the EU MDR means:

1. an invasive device which penetrates inside the body through the surface of the body, including through mucous membranes of body orifices with the aid or in the context of a surgical operation; and
2. a device which produces penetration other than through a body orifice.

Since the handpiece(s) do not fit this definition we believe the device to be non-invasive and therefor are Class 1, per Rule 1 of Annex 8 of the MDR which states “all non-invasive devices are classified as class I, unless one of the rules set out hereinafter applies”, i.e., rules 2, 3 and 4. Upon review of the applicable additional rules 2, 3 and 4, we have determined that they do not apply.

Can someone help with some guidance for this classification? Any help would be greatly appreciated.

 

[indubioush]

What is the intended medical purpose of the handpiece? Does it only have a medical purpose when combined with other devices/accessories?

 

[victorsyj]

Dental handpieces may be classified as Class IIa, as per Rule 9. I am answering this based on the previous EU Directives, which its Rule 9 is similar to the current Rule 9. You may have a look. DocsRoom - European Commission

 

[IZAKK]

What is the intended medical purpose of the handpiece? Does it only have a medical purpose when combined with other devices/accessories?

The medical purposes are general sawing and drilling, mainly orthopedic. Yes, only has a medical purpose when combined with accessory, i.e., a saw blade or Drill bit. Thanks!

 

[IZAKK]

Dental handpieces may be classified as Class IIa, as per Rule 9. I am answering this based on the previous EU Directives, which its Rule 9 is similar to the current Rule 9. You may have a look.

Thank you for the guidance! I will review that Rule as the devices are considered active.