MDD Classification of Bone Saw Handle

[Dave-h]

Morning all,

Just checking some clarification point for EU MDD classification.

The product in question is similar to a saw handle, to which attaches a blade which does the actual bone cutting.

The blade we're happy with as being class 2a rule 6 - non-active, surgically invasive & transient.

I am thinking that the handle to which the blade fits, would be a class 1 rule 1, (it is a manual device that is reusable) or maybe class 1 rule 6, if the handle could be described as an instrument.

Any ideas?

 

[SteveK]

MEDDEV 2.4.1 Rev9 gives one example/reference to an instrument handle; in this case a scalpel handle This is under rule 6. So I guess this would be the same for a saw handle.

Steve