Hello

We would like to sell our CE marked Class III products in Bulgaria.

The devices are only for professional use. Do we have to translate the Instructions For Use in to Bulgarian or is english sufficient?

The requirements are confusing. On one it's clearly stated yes on the other it's "english for professional use only". What is correct?

Thanks for your help.

I conferred with our RA department, and they gave me the attached table.

I got an answer from the Bulgarian Authority.

In accordance with the requirements of the Law on Medical Devices, as rule, the instruction for use have to be into Bulgarian language.
As an exception, it is not mandatory about MD for professional use. It is important the language of instruction for use to be into comprehensible language for the professionalists.


:applause:

Great sentence. That means for professional use english is OK?!?!?!?!

I got an answer from the Bulgarian Authority.

In accordance with the requirements of the Law on Medical Devices, as rule, the instruction for use have to be into Bulgarian language.
As an exception, it is not mandatory about MD for professional use. It is important the language of instruction for use to be into comprehensible language for the professionalists.


:applause:

Great sentence. That means for professional use english is OK?!?!?!?!

I think that you would have to be very - very - sure about the capabilities of the professionals to fully understand an IFU in a language that is not native for them. You are talking about a Class III product, so you are talking about something that is generally critical for the patient. Do you want to risk that a professional with a lack of understanding in english treats a patient in a manner that may pose a risk?? I wouldn't consider that in a million years.

There is the law of the land, there is common sense / ethics, and there is liability defense for your company.

Only once you can satisfy yourself that you have met all three requirements, can you proceed.

Wo got the confirmation from the health ministry that english is sufficient in our case.