Addition of a test reader to existing CE marked product.

[Karen747]

Hi Everyone,

Would be grateful if anyone has any insight on the regulatory requirements required when adding a test reader to an already on the market self declared CE marked product.

This test reader i'm assuming would be considered as used in combination with the test and for that fact "the whole connection system must be safe and not impair the specified performance of the device".

Would you think that if we have performed clinical trials on our already on the market test these would need to be repeated with the reader or is it acceptable to compare the reader and the test together against the test being carried out manually on three lots to show equivalence. Would the latter suffice?

Also in terms of technical files for the reader, would the reader now be seen as a medical device or would it still fall under the IVDD?

Thanks in advance,

Karen

 

[QAengineer13]

Hi Everyone,

Would be grateful if anyone has any insight on the regulatory requirements required when adding a test reader to an already on the market self declared CE marked product.

This test reader i'm assuming would be considered as used in combination with the test and for that fact "the whole connection system must be safe and not impair the specified performance of the device".

Would you think that if we have performed clinical trials on our already on the market test these would need to be repeated with the reader or is it acceptable to compare the reader and the test together against the test being carried out manually on three lots to show equivalence. Would the latter suffice?

Also in terms of technical files for the reader, would the reader now be seen as a medical device or would it still fall under the IVDD?

Thanks in advance,

Karen

Hi Karen,

My 2c's: There is not a lot of information in your post regarding your previous self declared CE marked product, so I cannot comment on this post without knowing any details, but I believe before you make any assumption:

"This test reader i'm assuming would be considered as used in combination with the test and for that fact "the whole connection system must be safe and not impair the specified performance of the device"."

The key question you need to ask (listed below) to the system along with the new test reader is :

1.Intended Use: Who is the device intended for? The objective intent of the manufacturer regarding the use of a product, process or service as reflected in the specifications, instructions and information provided by the manufacturer
2.Indication for Use: What are the conditions for use of the device, including the conditions of use prescribed, recommended, or suggested in the labelling or advertising of the device and other intended conditions of use?
3.Safety and Risk: What is the probable benefit to health from use of the device when weighted against any probable injury or illness from such use (risk /benefit analysis)?

Based on these preliminary questions and the impact to the existing Essential Requirements checklist would be my first starting point.....

 

[Karen747]

Hi Karen,

My 2c's: There is not a lot of information in your post regarding your previous self declared CE marked product, so I cannot comment on this post without knowing any details, but I believe before you make any assumption:

"This test reader i'm assuming would be considered as used in combination with the test and for that fact "the whole connection system must be safe and not impair the specified performance of the device"."

The key question you need to ask (listed below) to the system along with the new test reader is :

1.Intended Use: Who is the device intended for? The objective intent of the manufacturer regarding the use of a product, process or service as reflected in the specifications, instructions and information provided by the manufacturer
2.Indication for Use: What are the conditions for use of the device, including the conditions of use prescribed, recommended, or suggested in the labelling or advertising of the device and other intended conditions of use?
3.Safety and Risk: What is the probable benefit to health from use of the device when weighted against any probable injury or illness from such use (risk /benefit analysis)?

Based on these preliminary questions and the impact to the existing Essential Requirements checklist would be my first starting point.....

Hi QAengineer13,

Apologies I should have stated that the current IVD device is a qualitative lateral flow assay.

The reader will be intended for use with the lateral flow assay for professional use only. We will have to update our current IFU to include the reader as we will be an OEM.

The benefit of having the reader outweighs the risk as it takes out the risk of people interpreting the test incorrectly.

Thanks for the reply