Compatibility studies - Medicinal Product and Medical Device

[RegulatoryUS_EU]

A Company wants to authorise their medicinal product in Europe. The Medicinal Product is contained in cartridges and will be administered with an already CE Marked specific re-usable pen (medical device, MD), not a pre-filled pen injector.

According to EMA draft quality guideline from 2019, the compatibility between the drug product and the MD should be assessed on bases of chemical and physical stability (i.e. stability, precipitation and sorption).

I would like to ask you how compatibility will be demonstrated in this case where the medicinal product is not in direct contact with the MD. Compatibility between the medicinal product and the cartridges (primary packaging) has been already conducted

Thus, should an in-use stability study performed with the drug product and the MD be enough to demonstrate compatibility? Or shall the applicant perform other studies to show compatibility between the drug product and the MD?

Thank you in advanced.

 

[saurabhdubey]

Hi, I have a question regarding the IFU.

I would like to remove list of compatible device from the IFU and wish to create a separate declaration of compatibility. This declaration will have list of compatible devices and it will be provided to customer as per regulatory language requirements. Do you think this is possible as per EU MDR.

 

[Ronen E]

Hi, I have a question regarding the IFU.

I would like to remove list of compatible device from the IFU and wish to create a separate declaration of compatibility. This declaration will have list of compatible devices and it will be provided to customer as per regulatory language requirements. Do you think this is possible as per EU MDR.

Please provide some context. What is the product we're discussing?

 

[saurabhdubey]

Thanks, I will try to brief here.

I have X product with IFU. This IFU also includes the list of compatible devices with X product.

But now I am planning to update the IFU by removing list of compatible devices and create a separate declaration. The new declaration will have list of compatible devices and can be shared to customers translated as and when required.

Que 1: Is that possible to keep separate declaration of compatibility?
Que 2: If, yes, can I provide the declaration as eIFU way?

 

[Ronen E]

-- "What is the product we're discussing?"
-- "I have X product with IFU."

Question not answered. Cannot proceed.

 

[EmiliaBedelia]

Thanks, I will try to brief here.

I have X product with IFU. This IFU also includes the list of compatible devices with X product.

But now I am planning to update the IFU by removing list of compatible devices and create a separate declaration. The new declaration will have list of compatible devices and can be shared to customers translated as and when required.

Que 1: Is that possible to keep separate declaration of compatibility?
Que 2: If, yes, can I provide the declaration as eIFU way?

1) Probably not. For devices that are intended to be used in combination with other devices, you need to provide information in the IFU on how to select an appropriate combination.
2). Since you have not provided info on what your device is we cannot tell you the answer to this one. Providing only an eIFU is only acceptable in specific situations (software, devices with built-in screen displays, fixed installed medical devices, implantable devices - must only be intended for use by professionals).
You are allowed to provide an eIFU in addition to paper for other devices not in those categories if you want, but you still need to provide the paper copy and the eIFU needs to match it (ie, putting a piece of paper in the box that says "See myifu.com" is not acceptable).