Regulatory Open Forum

Dear all,

Please I need your advice on one point.

For a medical class IIb implantable device system  consist of Plate, screws and cutting guide , clinical is it mandatory?

I explain myself, I read that Clinical investigations need not be performed in the following cases – sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips or connectors for which the clinical evaluation is based on sufficient clinical data and is in compliance with the relevant product-specific common specification, where such a common specification is available.

However , this list does not include the cutting guide class IIa; does it mean that , clinical investigation is mandatory before marketing the system?

Or only for cutting guide class IIa ,is it possible to use equivalence arguments by showing that the device has the same technical, biological, and clinical characteristics, and demonstrate sufficient literature clinical data on that equivalent device even if may be harder to make and  can expect to be challenged by the notified body without an agreement to access technical documentation for the equivalent device (required for implants and class III devices)?

Thank you in advance for your help.

Rgds,




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Nadine Adia
Quebec QC
Canada
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This message was posted by a user wishing to remain anonymous

​Dear Nadine,

Not an expert, but per Canada Medical Devices Regulations,

Original Message:
Sent: 29-Jun-2021 01:03
From: Nadine Adia
Subject: System clinical investigation under MDR EU

Dear all,

Please I need your advice on one point.

For a medical class IIb implantable device system  consist of Plate, screws and cutting guide , clinical is it mandatory?

I explain myself, I read that Clinical investigations need not be performed in the following cases – sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips or connectors for which the clinical evaluation is based on sufficient clinical data and is in compliance with the relevant product-specific common specification, where such a common specification is available.

However , this list does not include the cutting guide class IIa; does it mean that , clinical investigation is mandatory before marketing the system?

Or only for cutting guide class IIa ,is it possible to use equivalence arguments by showing that the device has the same technical, biological, and clinical characteristics, and demonstrate sufficient literature clinical data on that equivalent device even if may be harder to make and  can expect to be challenged by the notified body without an agreement to access technical documentation for the equivalent device (required for implants and class III devices)?

Thank you in advance for your help.

Rgds,




------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------

This message was posted by a user wishing to remain anonymous

Oh, I am sorry. Now I see EU in the subject line - Not Canada.

So, 2017/745, Article 61, point 4:

In the case of implantable devices and class III devices, clinical investigations shall be performed, except if:

- the device has been designed by modifications of a device already marketed by the same manufacturer,
- the modified device has been demonstrated by the manufacturer to be equivalent to the marketed device, in accordance with Section 3 of Annex XIV and this demonstration has been endorsed by the notified body, and
- the clinical evaluation of the marketed device is sufficient to demonstrate conformity of the modified device with the relevant safety and performance requirements...
In addition, clinical investigations need not be performed in the cases referred to in paragraph 6...


But is the cutting guide implantable?
​

Original Message:
Sent: 29-Jun-2021 01:03
From: Nadine Adia
Subject: System clinical investigation under MDR EU

Dear all,

Please I need your advice on one point.

For a medical class IIb implantable device system  consist of Plate, screws and cutting guide , clinical is it mandatory?

I explain myself, I read that Clinical investigations need not be performed in the following cases – sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips or connectors for which the clinical evaluation is based on sufficient clinical data and is in compliance with the relevant product-specific common specification, where such a common specification is available.

However , this list does not include the cutting guide class IIa; does it mean that , clinical investigation is mandatory before marketing the system?

Or only for cutting guide class IIa ,is it possible to use equivalence arguments by showing that the device has the same technical, biological, and clinical characteristics, and demonstrate sufficient literature clinical data on that equivalent device even if may be harder to make and  can expect to be challenged by the notified body without an agreement to access technical documentation for the equivalent device (required for implants and class III devices)?

Thank you in advance for your help.

Rgds,




------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------