Medical Device Classification of a Needle Holder

[zolakeene]

Hi Guys

Help what classification would a needle holder be?

I or 2A

 

[Marcelo]

Re: Classification of a needle holder

Hello Zolakeene

I've just moved your question to a new thread.

Regarding classification, please take a look at the guidance document "Classification of Medical Devices".

 

[Sam Lazzara]

Need more information. Please provide a more complete description. Sterile? Non-sterile? Single use? Reusable? Provide indications for use.

You seem to be asking about European medical device classification?
Each regulatory agency/regime has their own rules for classification.

 

[SteveK]

As indicated it may depend on 'singe use' or 'reusable'.

Under Annex IX of MDD 93/42/EEC I believe a needle holder would be covered under rule 6 i.e. "All surgically invasive devices intended for transient use are in Class IIa unless the are:"

And here is the point:

"....... unless they are:

- reusable surgical instruments, in which case they are in Class I".

As a matter of interest look at section 3.10 of the attachment (i.e. needle holder reference) that comes with this supplier's CE Certificate.

https://www.cohan.org.co/content/43/proveedores/3/kardex049/adjuntos/1/1316186718.pdf

Steve

 

[drewsky1]

We have surgical tips which are connected to an electrosurgical generator which will remove body fluids and cut, coagulate tissue which we have classified per MDD Rule 11 and as Class 2b device as we feel it is under the "potentially hazardous" category. Not sure if this is fitting for this device, any input would be appreciated.

 

[Ronen E]

Asking about a medical device's classification without sharing the detailed intended use (e.g. IFU / user manual) is like asking someone to drive a car blindfolded.

 

[zolakeene]

thanks for you guidence
My issue was as the needle is invasive but the holder is not I was a liitle con fussed as would it be classed as an accesories therefore 2a?
thanks again

 

[J0anne]

thanks for you guidence
My issue was as the needle is invasive but the holder is not I was a liitle con fussed as would it be classed as an accesories therefore 2a?
thanks again

Late again Mr. Keene ... remember this - the classification is always based on the intended purpose. The intended use of the holder is different to that of the needle. Classify them both seperately.

 

[wrodnigg]

A needle holder (as long as it is not invasive) would go to class I, and since I assume its sterilization, it would be class Is.

 

[zolakeene]

thanks guys