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?
"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?