Reusable Surgical Instruments - Definition per Annex IX of Directive 93/42/EEC

[NinaW]

Dear all,

Can anyone help me with the interpretation of the definition for “Reusable surgical Instrument" as per section 1.3 of Annex IX of Directive 93/42/EEC?

“Instrument intended for surgical use by cutting, drilling, sawing, scratching,
scraping, clamping, retracting, clipping or similar procedures, without
connection to any active medical device and which can be reused after
appropriate procedures have been carried out.”

1. Does “without connection to any active medical device” means not intended for connection to an active device? Or does it mean not supplied (sold) together with an active device?

2. For instance, reusable drills (to drill the bone) are, in order to achieve their intended use attached to an “an active device”. If sold together with the powered unit, the Class applied would be IIa (if the powered unit is Classified as Class IIa). What if the surgical drills are sold separately? What classification applies?

Thank you very much in advance,

Nina

[Mikishots]

In Reply to Parent Post by NinaW

Dear all,

Can anyone help me with the interpretation of the definition for “Reusable surgical Instrument" as per section 1.3 of Annex IX of Directive 93/42/EEC?

“Instrument intended for surgical use by cutting, drilling, sawing, scratching,
scraping, clamping, retracting, clipping or similar procedures, without
connection to any active medical device and which can be reused after
appropriate procedures have been carried out.”

1. Does “without connection to any active medical device” means not intended for connection to an active device? Or does it mean not supplied (sold) together with an active device?

2. For instance, reusable drills (to drill the bone) are, in order to achieve their intended use attached to an “an active device”. If sold together with the powered unit, the Class applied would be IIa (if the powered unit is Classified as Class IIa). What if the surgical drills are sold separately? What classification applies?

Thank you very much in advance,

Nina

They're talking about any device that relies on the correct functioning of a driving or controlling device. A drill bit would be considered passive.

[NinaW]

Thank you very much for a reply! Drill bit falls than within Class I according to Rule 6. What about the DRILL itself (tool fitted with a drill bit, which enables rotation). Drills (with fitted drill bit) are sold as an accessory (they intend to be connected to an electrical unit)...

[c.mitch]

Hello,

If the drill is connected to an active device, it is class IIa as per rule #6.
I suppose in your case the active device is a micro motor + foot operated control unit. It is probably class IIa as per rule #9.

[pkost]

"without connection to any active medical device"...means if it can/should be attached to an active device this rule does not apply, therefore a drill bit that is intended to be connected to an active device is IIa - this can be found in the MEDDEV guidance....

The guidance specifically seperates drill bits and drill bits for active devices; the same can be said for saws.


Power tools generally fall into IIa (rule 9). This can also be found in the meddev

[NinaW]

Thank you very much for your replies. It is clear now!!!