Regulatory Open Forum

Hi Everyone,

I would like to ask a question regarding the instructions for use of a medical device.

My situation is as follows. My company has wide range of similar products with the same intended use and technological characteristics. There is minimum features which change. We would like to start selling in Hungary, but unfortunately we need to translate all the IFUs of all of our products in Hungarian language. 

In order to minimize the workload and to avoid having to update our current IFUs in every country we sell,  I thought it would be better to create a unique IFU for Hungary alone, including all the models/product families of our products. Is it possible to do that?  If we have different products with the same intended use, is it possible to create a unique IFU for all of them at the same time, separating the products in the IFU?

Thanks in advance ,

Regards,

Hi Everyone,

I would like to ask a question regarding the instructions for use of a medical device.

My situation is as follows. My company has wide range of similar products with the same intended use and technological characteristics. There is minimum features which change. We would like to start selling in Hungary, but unfortunately we need to translate all the IFUs of all of our products in Hungarian language. 

In order to minimize the workload and to avoid having to update our current IFUs in every country we sell,  I thought it would be better to create a unique IFU for Hungary alone, including all the models/product families of our products. Is it possible to do that?  If we have different products with the same intended use, is it possible to create a unique IFU for all of them at the same time, separating the products in the IFU?

Thanks in advance ,

Regards,

Hi Everyone,

I would like to ask a question regarding the instructions for use of a medical device.

My situation is as follows. My company has wide range of similar products with the same intended use and technological characteristics. There is minimum features which change. We would like to start selling in Hungary, but unfortunately we need to translate all the IFUs of all of our products in Hungarian language. 

In order to minimize the workload and to avoid having to update our current IFUs in every country we sell,  I thought it would be better to create a unique IFU for Hungary alone, including all the models/product families of our products. Is it possible to do that?  If we have different products with the same intended use, is it possible to create a unique IFU for all of them at the same time, separating the products in the IFU?

Thanks in advance ,

Regards,

Hi Everyone,

I would like to ask a question regarding the instructions for use of a medical device.

My situation is as follows. My company has wide range of similar products with the same intended use and technological characteristics. There is minimum features which change. We would like to start selling in Hungary, but unfortunately we need to translate all the IFUs of all of our products in Hungarian language. 

In order to minimize the workload and to avoid having to update our current IFUs in every country we sell,  I thought it would be better to create a unique IFU for Hungary alone, including all the models/product families of our products. Is it possible to do that?  If we have different products with the same intended use, is it possible to create a unique IFU for all of them at the same time, separating the products in the IFU?

Thanks in advance ,

Regards,

Hi Everyone,

I would like to ask a question regarding the instructions for use of a medical device.

My situation is as follows. My company has wide range of similar products with the same intended use and technological characteristics. There is minimum features which change. We would like to start selling in Hungary, but unfortunately we need to translate all the IFUs of all of our products in Hungarian language. 

In order to minimize the workload and to avoid having to update our current IFUs in every country we sell,  I thought it would be better to create a unique IFU for Hungary alone, including all the models/product families of our products. Is it possible to do that?  If we have different products with the same intended use, is it possible to create a unique IFU for all of them at the same time, separating the products in the IFU?

Thanks in advance ,

Regards,