Class I Medical Device Accessory with Actual Risk

[HelviReg]

Hi everyone,

For some reasons I won't developed here our NB has informed us that we have "surclassified" one of our devices we market. In their opinion, this device (an accessory actually) is a Class I device per the annex IX of the MDD.

This accessory is intended to be used with our main parent device, a class IIb therapeutic ultrasound device. The purpose of this accessory is similar to the coupling gel of an ultrasound scanner: enabling the transmission of the ultrasound energy from the machine head to the tissues. However, in our case, this accessory is not gel but a plastic pouch filled with a specific liquid inserted between the transducer and the skin.

Based on the annex IX, I actually agree that this accessory is a Class I device per rule 1. Especially because it cannot be classified as an active medical device, according to following part of the definition of an active device:
"Medical devices intended to transmit energy, substances or other elements between an active medical device and the patient, without any significant change, are not considered to be active medical devices"

Here is my problem. The annex IX should be a risk-based classification scheme. Therefore if our accessory becomes a Class I (non sterile/no measuring function) device, it means that there is no/little risk associated with its use and then it can be self-certified.

But there are risks associated with this accessory. Of course the risks originate from the ultrasound parent device, but if this accessory is not properly designed, verified, validated and manufactured, the parent device may harm patients.
Some parts of the validation of the parent device are done with this accessory, but still, putting this accessory out of the CE mark/ISO 13485 audit scope seems hazardous to me.

Your opinion will be much appreciated

Thank you !

 

[chris1price]

Re: Class I Medical Device Accessory with Actual Risk?

Hi, while a Class I device is self-certified, it does not mean you are outside of CE Marking and ISO13485.

Before you can Self-Certify, you must meet the requirements of Annex VII. This requires maintaining a technical file that contains all the usual elements, incuding risk analysis, meeting essential requirements, clinical evaluation, etc. You also need a PMS system in place.

The "self-certification" just means you don't need to have the files reviewed in advance by a Notified Body. It is not uncommon for a competent authority to ask to see the files.

 

[HelviReg]

Re: Class I Medical Device Accessory with Actual Risk?

Thanks for your reply Chris.

Indeed a Class I MD manufacturer has to fulfill the obligations of, at least, the annex VII. But no NB is involved.

In our case, we market a IIb MD so we are audited every year per the annex II. But documentation of that accessory (including the tech file) won't be part of it any more.

Through my post I'm actually challenging the risk-based approach of the annex IX which has its limits in classifying devices.

 

[Ronen E]

Re: Class I Medical Device Accessory with Actual Risk?

while a Class I device is self-certified, it does not mean you are outside of CE Marking and ISO13485.

(Emphasis added)

While I mostly agree, class I devices (NSNM) don't require a QMS under the applicable conformity assessment procedure and thus don't call for ISO 13485 or similar.

Of course it would make sense to voluntarily apply an ISO 13485 system to a device/accessory where the org already has higher classification devices.

 

[Ronen E]

Hi everyone,

For some reasons I won't developed here our NB has informed us that we have "surclassified" one of our devices we market. In their opinion, this device (an accessory actually) is a Class I device per the annex IX of the MDD.

This accessory is intended to be used with our main parent device, a class IIb therapeutic ultrasound device. The purpose of this accessory is similar to the coupling gel of an ultrasound scanner: enabling the transmission of the ultrasound energy from the machine head to the tissues. However, in our case, this accessory is not gel but a plastic pouch filled with a specific liquid inserted between the transducer and the skin.

Based on the annex IX, I actually agree that this accessory is a Class I device per rule 1. Especially because it cannot be classified as an active medical device, according to following part of the definition of an active device:
"Medical devices intended to transmit energy, substances or other elements between an active medical device and the patient, without any significant change, are not considered to be active medical devices"

Here is my problem. The annex IX should be a risk-based classification scheme. Therefore if our accessory becomes a Class I (non sterile/no measuring function) device, it means that there is no/little risk associated with its use and then it can be self-certified.

But there are risks associated with this accessory. Of course the risks originate from the ultrasound parent device, but if this accessory is not properly designed, verified, validated and manufactured, the parent device may harm patients.
Some parts of the validation of the parent device are done with this accessory, but still, putting this accessory out of the CE mark/ISO 13485 audit scope seems hazardous to me.

Your opinion will be much appreciated

Thank you !

Under the MDD an Accessory is defined as something that enables the parent device to achieve its intended use. Thus if this pouch is really an Accessory under the MDD (let's assume it is), the parent device shouldn't be able to perform properly if that pouch is flawed or misused. As a consequence, all risks associated with using the pouch with the parent device become integral risks of the parent device and as such should be thoroughly addressed as part of the parent device's assessment and certification. In my opinion that closes the loop quite well.

 

[HelviReg]

Thank you Ronen. That's my opinion too. I'm just not sure it will be that way.. especially with the increased amount of work for the NB induced by the MDR !

 

[tarler]

Sorry for the late response but I have a very similar situation to iVivien (OP).
First I agree with iVivien about the risk based approach and it makes no sense for a NB to give a non-conformity that you were too conservative. The problem is the MDD should have statements saying ... at least class II and ... may be classified as class I to give allowances for more conservative classification. I believe that is the intent as evidenced by their example where they clearly stated in the "practical example" that the company can CHOOSE to classify all the parts as class II.

My intentions however is a slightly different in that I want our accessory to be classified class IIb because we already are being audited and such with our NB and don't want to pay or deal with our AR and the extra registration fees.

 

[Ronen E]

Hello tarler, welcome to the discussion

I'm not sure what you meant by

and don't want to pay or deal with our AR and the extra registration fees.

Either way, if you don't have a registered place of business inside the EU you have to "deal with an AR" regardless of device classification and whether they register devices on your behalf or not.