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
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