Manufacturing Address - Section 5.3 of EN 591 - In Vitro Diagnostic IFU

M

Mark M. Sweeny

Hello.

According to Section 5.3 of EN 591, Instructions for use for in vitro diagnostic instruments for professional use, the name and address of the manufacturer shall be given. Section EN 980, Graphical Symbols for use in the Labeling of Medical Devices, requires the use of the manufacturing symbol next to the address.

My question is does the entire manufacturer address (street, city, etc.) need to be included or is country sufficient. For example, Made in USA.

All responses are appreciated.

Thanks,

Mark
 

somashekar

Leader
Admin
Re: Manufacturing Address

Hello.

According to Section 5.3 of EN 591, Instructions for use for in vitro diagnostic instruments for professional use, the name and address of the manufacturer shall be given. Section EN 980, Graphical Symbols for use in the Labeling of Medical Devices, requires the use of the manufacturing symbol next to the address.

My question is does the entire manufacturer address (street, city, etc.) need to be included or is country sufficient. For example, Made in USA.

All responses are appreciated.

Thanks,

Mark
Consider this as the address that appeares on your CE certificate .....
A letter dropped in the postbox with that address must be able to reach you.
 
M

Mark M. Sweeny

Re: Manufacturing Address

Thanks. Very helpful. But would the address have to go on the instrument or could it be in the manual?
 

somashekar

Leader
Admin
Re: Manufacturing Address

Thanks. Very helpful. But would the address have to go on the instrument or could it be in the manual?
It all comes around to providing information to the user. If the instrument is so small and smaller is the label, there is no logic in having the address put in microprint. So the next best place(s) are the manual / packaging label.
 

pkost

Trusted Information Resource
Re: Manufacturing Address

EN 980 says that you don't have to include the address on the immediate container as specified in EN 375, 376, 591 and 592 except when it is also the outer container

EN 980 also refers to EN 1041 which is "Information supplied by the manufacturer of medical devices". Although it is in the section of active devices it says that the address does not need to be complete ... just "sufficient detail that the manufacturer may be contacted, for example name or trade name, post code and country"
 
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