Regulatory Open Forum

Hi RAPS
 IVD product -   classification .MDR 2017/746 

I would like to ask you for feedback if our  classification is correct and the product falls into class A acc. to Annex VIII -IVDR 2017/746

Here is define intended purpose for  both IVD producs:

1)Antimycotic susceptibility discs are used for  the determination of the susceptibility of microscopic fungi to antimycotic agents in vitro. It is possible to get the information about actual susceptibility of the tested fungal isolate by a simple diffusion method after 18-24 hrs already.
The results of the antimycotic antibiogram make it possible to start a rational treatment of the mycotic infection.

2)OPTOCHIN diagnostic discs are used for simple  presumptive differentiation of Streptococcus pneumoniae from other viridans streptococci.

Note: Products detect infection, not life-threatening disease

As a first step, we have started to comply with Annex VIII, i.e. the classification rules.

According to Annex VIII we classified those products in the Class A -Rule 5, as instrument

2.5.   Rule 5

The following devices are classified as class A

We chose this purpose from Article 2 Definition:
"Physiological or pathological process or state " because these products help to determine a specific treatment, ie the patient's state

note:

We also went through all the other rules, however, none of them matched the definition of the intended purpose of use of these 2 types of IVD.

Thanks
Evangelos

Hi RAPS
 IVD product -   classification .MDR 2017/746 

I would like to ask you for feedback if our  classification is correct and the product falls into class A acc. to Annex VIII -IVDR 2017/746

Here is define intended purpose for  both IVD producs:

1)Antimycotic susceptibility discs are used for  the determination of the susceptibility of microscopic fungi to antimycotic agents in vitro. It is possible to get the information about actual susceptibility of the tested fungal isolate by a simple diffusion method after 18-24 hrs already.
The results of the antimycotic antibiogram make it possible to start a rational treatment of the mycotic infection.

2)OPTOCHIN diagnostic discs are used for simple  presumptive differentiation of Streptococcus pneumoniae from other viridans streptococci.

Note: Products detect infection, not life-threatening disease

As a first step, we have started to comply with Annex VIII, i.e. the classification rules.

According to Annex VIII we classified those products in the Class A -Rule 5, as instrument

2.5.   Rule 5

The following devices are classified as class A

We chose this purpose from Article 2 Definition:
"Physiological or pathological process or state " because these products help to determine a specific treatment, ie the patient's state

note:

We also went through all the other rules, however, none of them matched the definition of the intended purpose of use of these 2 types of IVD.

Thanks
Evangelos

Hello Richards

Thank you so much for your quick  contribution and feedback.

So then you maybe ask the question: is this an IVD medical device? Or could it just be classified as a laboratory test?  With the regulations now, it is definitely important to think about the intended use and also the intended purposes of devices to maybe document the rationale for the classification chosen

I have not addressed the question of whether these products are IVD/laboratory tests? at all and thank you for it, I will deal with it in the company.

Kind regards

Evangelos  Tavandžis_QMD

Lead Auditor ISO 13 485:2016 / CE značka MDD/MDR- oblast zdravotnických prostředků/ Medicla devices

Poradenství v oblasti zdravotnických prostředků / Consultant -Medical devices

Interní a externí audity dle MDD/MDR/ Internal and external audits MDD/MDR

Hi RAPS
 IVD product -   classification .MDR 2017/746 

I would like to ask you for feedback if our  classification is correct and the product falls into class A acc. to Annex VIII -IVDR 2017/746

Here is define intended purpose for  both IVD producs:

1)Antimycotic susceptibility discs are used for  the determination of the susceptibility of microscopic fungi to antimycotic agents in vitro. It is possible to get the information about actual susceptibility of the tested fungal isolate by a simple diffusion method after 18-24 hrs already.
The results of the antimycotic antibiogram make it possible to start a rational treatment of the mycotic infection.

2)OPTOCHIN diagnostic discs are used for simple  presumptive differentiation of Streptococcus pneumoniae from other viridans streptococci.

Note: Products detect infection, not life-threatening disease

As a first step, we have started to comply with Annex VIII, i.e. the classification rules.

According to Annex VIII we classified those products in the Class A -Rule 5, as instrument

2.5.   Rule 5

The following devices are classified as class A

We chose this purpose from Article 2 Definition:
"Physiological or pathological process or state " because these products help to determine a specific treatment, ie the patient's state

note:

We also went through all the other rules, however, none of them matched the definition of the intended purpose of use of these 2 types of IVD.

Thanks
Evangelos

Dear Evangelos, 

Is this a new product or is it already on the market?

The intended use statements 1) and 2) only explain the test principle. Given that the analysis takes place after sampling, IVDR, not MDR is the applicable legislation. Please note that IVDR is also quite explicit regarding the Intended purpose, see  Annex I paragraph 20.4.1 (c) "the device's intended purpose:"

For the proper classification of your devices you need ​to describe who the users of these products are, and the clinical context in which these products are used (aka what do users do with the information provided by the test). Risk management file is also a vital source of information: the devices you describe test pathogenic microorganisms, so from the patient and public health perspective: what are the consequences of the false positive or false negative result?
Will they receive an ineffective treatment? Can they infect others? 

I know that nowadays company management may pressure it QA/RA specialists to try every trick in the book to end in Class A, which the only one that does not require Notified body approval, but this must be justified beyond doubt. In this case, if the tests are for characterization of infectious pathogens, Class B is seems the most appropriate choice.
Kind regards,
Agnieszka 

Hello Richards

Thank you so much for your quick  contribution and feedback.

So then you maybe ask the question: is this an IVD medical device? Or could it just be classified as a laboratory test?  With the regulations now, it is definitely important to think about the intended use and also the intended purposes of devices to maybe document the rationale for the classification chosen

I have not addressed the question of whether these products are IVD/laboratory tests? at all and thank you for it, I will deal with it in the company.

Kind regards

Evangelos  Tavandžis_QMD

Lead Auditor ISO 13 485:2016 / CE značka MDD/MDR- oblast zdravotnických prostředků/ Medicla devices

Poradenství v oblasti zdravotnických prostředků / Consultant -Medical devices

Interní a externí audity dle MDD/MDR/ Internal and external audits MDD/MDR

Hi RAPS
 IVD product -   classification .MDR 2017/746 

I would like to ask you for feedback if our  classification is correct and the product falls into class A acc. to Annex VIII -IVDR 2017/746

Here is define intended purpose for  both IVD producs:

1)Antimycotic susceptibility discs are used for  the determination of the susceptibility of microscopic fungi to antimycotic agents in vitro. It is possible to get the information about actual susceptibility of the tested fungal isolate by a simple diffusion method after 18-24 hrs already.
The results of the antimycotic antibiogram make it possible to start a rational treatment of the mycotic infection.

2)OPTOCHIN diagnostic discs are used for simple  presumptive differentiation of Streptococcus pneumoniae from other viridans streptococci.

Note: Products detect infection, not life-threatening disease

As a first step, we have started to comply with Annex VIII, i.e. the classification rules.

According to Annex VIII we classified those products in the Class A -Rule 5, as instrument

2.5.   Rule 5

The following devices are classified as class A

We chose this purpose from Article 2 Definition:
"Physiological or pathological process or state " because these products help to determine a specific treatment, ie the patient's state

note:

We also went through all the other rules, however, none of them matched the definition of the intended purpose of use of these 2 types of IVD.

Thanks
Evangelos