MDR Annex VIII, Rule 6 Classification - Implication for lower risk CV products?

#1
Comparing classification rules MDD Annex IX, Rule 6 vs. MDR Annex VIII, Rule 6 regarding surgically invasive transient devices, the regulators have added the following statement (shown only in part for brevity) :

"All surgically invasive devices intended for transient use are in Class IIa unless they ..
- are intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system, in which case they are classified as class III"

This implies sponsors of well-understood, low risk cv products such as guide wires, sheaths and guide catheters will be obliged to file full Class III Dossiers and all the associated burden of a Class III product including possible clinical data. As a device manufacturer, how are you approaching this?
 
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craiglab

Involved In Discussions
#2
How is this any different than under the MDD considering MEDDEV 2. 4/1 Rev. 9, page 32
"- intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III"

(it's not)
 
#3
The statement you cite from the MDD remains as a separate line item in the MDR version, so clearly there is something different.
The guidance cites guidewires and introducers as examples, but a qualifying note below implies if the accessory is not "dedicated" with an intended purpose to "specifically control, diagnose, monitor or correct a defect ...", then it would be classified as IIa.
A simple guidewire or sheath does not control (eg, pacemaker lead), monitor (eg, Swan-Ganz cath), diagnose (eg, ICE), or correct a defect of the heart (eg, PFO closure).
So does the added statement close that gap?
I'm hoping someone with product experience of this type might chime in on this interpretation.
 

dgrainger

Trusted Information Resource
#4
Hadn't noticed that change. Pretty much makes the first sub-clause redundant - now anything that is "specifically for use in direct contact..." will be class III.
 

mpfizer

Involved In Discussions
#5
Comparing classification rules MDD Annex IX, Rule 6 vs. MDR Annex VIII, Rule 6 regarding surgically invasive transient devices, the regulators have added the following statement (shown only in part for brevity) :

"All surgically invasive devices intended for transient use are in Class IIa unless they ..
- are intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system, in which case they are classified as class III"

This implies sponsors of well-understood, low risk cv products such as guide wires, sheaths and guide catheters will be obliged to file full Class III Dossiers and all the associated burden of a Class III product including possible clinical data. As a device manufacturer, how are you approaching this?

What about same Rule but transient surgically invasive reusable products which are attached to a power drill eg. a drill bit or reamer attached to a battery or electric drill ? will it be Class 1 or .....

Michelle
 
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