Brainstorm: is every reusable medical device class Ir?

[emina4]

Hello everyone,
I'm trying to properly classify our medical device accessory, which helps the main medical device (class III, non active) to achieve its intended purpose. It is a reusable, reprocessible, resterilizable (everything re-) medical device which is not a surgical instrument. So it does not fall into the MDR definition of a 'reusable surgical instrument' because it does not drill, sew, etc standalone, and it does not work standalone but only in connection with our main device (supports its function). The only box it ticks is that it is reusable.

Now, how strict is this MDR definition which automatically implies the Ir classification? I would classify this as a simple class I device, but the fact that it is reusable and will be reprocessed/resterilized/cleaned, because of that I'm struggling if I need to classify it as Ir so NB can assess these aspects? Any thoughts or experiences?

Thanks

 

[Cloud808]

Per Article 52(7), notified body involvement for a Class I device would only pertain to a reusable surgical instrument. (or sterile/measurement).

‘Reusable surgical instrument’ means an instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out. (Ar. 2)

If your device/accessory is Class I and does not fit this definition based on its intended purpose, then my understanding is that you would not require notified body involvement. When you mention that it only works in connection with the 'main device', I am thinking that the "without a connection to an active device" perhaps applies? Can the 'main device' be considered active? You should be able to justify your decision using the definition.

However, you mention that (everything re-) applies, so Im wondering if the device is placed on the market in sterile condition? If so, then the device would be Class I(s).

 

[planB]

Reusable medical devices may be of any class.

A word of caution: if you claim your reusable device being an indispensable and non-generic accessory to help your "main" medical device of class III achieve its intended purpose, you will mostly likely be forced by your NB to classify your reusable device also as being class III.

 

[dgrainger]

Is it surgically invasive in its own right?

 

[emina4]

Reusable medical devices may be of any class.

A word of caution: if you claim your reusable device being an indispensable and non-generic accessory to help your "main" medical device of class III achieve its intended purpose, you will mostly likely be forced by your NB to classify your reusable device also as being class III.

Sure, reusable medical device may be of any class - probably should have worded that differently: Should every class I reusable device automatically be class Ir ?
Thing is I'm confused with the class Ir definition in MDR because it only mentions 'reusable surgical instrument' to be class Ir. While this is not a surgical instrument, but it is reusable and it is class I, does this make it class Ir?
Regarding your comment, you're right, I should probably consult NB to see if they see this even as class III?

 

[emina4]

Is it surgically invasive in its own right?

No, it is not. It is a metal structure that stabilizes the implantation catheter. Implantation catheter being class III, non active device, and this accessory helps the user by providing support and stability to the catheter, so the user can better maneuver with the catheter.
It is reusable because after every use it will be cleaned and resterilized for the next implantation..

 

[Raisin picker]

A look in MDCG 2021-24 might help, e.g. page 5, 1st paragraph: "In addition, and according to Article 52(7)(a), (b) and (c), Class I devices can be further subdivided into Is – sterile condition, Im – measuring function and Ir – reusable surgical." [emphasis by me].
Afaik, there is no mentioning of Ir, Is or Im in the MDR, and the MDCG also uses it just once as quoted.

 

[EmiliaBedelia]

There are reusable devices that are just plain Class I (not 1r). Surgical sterilization trays/cases are an example. A patient positioner is another example. An accessory/component of a surgical system, such as a wrench or calibration tool, could be another. In my experience the key differentiation with reusable surgical instruments is that the sterility is critical to the intended use of the device since it is invasive. Therefore the sterilization parameters and the instructions for determining when the device has reached the end of its lifetime are necessary to ensure the safety of the device. Those 2 aspects are basically the only thing the NB cared about when reviewing Class Irs.

Heartily recommending the MDCG 2021-24 guidance, this is extremely helpful for applying the classification rules. The more specifically you can describe the exact function of this component, the easier it will be to justify its classification as Class I.

 

[emina4]

There are reusable devices that are just plain Class I (not 1r). Surgical sterilization trays/cases are an example. A patient positioner is another example. An accessory/component of a surgical system, such as a wrench or calibration tool, could be another. In my experience the key differentiation with reusable surgical instruments is that the sterility is critical to the intended use of the device since it is invasive. Therefore the sterilization parameters and the instructions for determining when the device has reached the end of its lifetime are necessary to ensure the safety of the device. Those 2 aspects are basically the only thing the NB cared about when reviewing Class Irs.

Heartily recommending the MDCG 2021-24 guidance, this is extremely helpful for applying the classification rules. The more specifically you can describe the exact function of this component, the easier it will be to justify its classification as Class I.

Thank you so much. Great response!