Hii..
1. I found from 98/79/EC IVD directive,"Use by date" has to be placed for IVD instruments. But for instruments, how can we find/develop expiry dates??
Is it compulsory to put expiry date on labels??
Or any requirement to put MANUFACTURING date for INSTRUMENTS?
2. EC Rep address: Is it required to put EC Rep ADDRESS BOTH on primary label and IFU/User Manual?? Or is it ok, if we place the address, on ANY ONE of them??
Pls reply.
Thanks,
Sreenu
1. I found from 98/79/EC IVD directive,"Use by date" has to be placed for IVD instruments. But for instruments, how can we find/develop expiry dates??
Is it compulsory to put expiry date on labels??
Or any requirement to put MANUFACTURING date for INSTRUMENTS?
2. EC Rep address: Is it required to put EC Rep ADDRESS BOTH on primary label and IFU/User Manual?? Or is it ok, if we place the address, on ANY ONE of them??
Pls reply.
Thanks,
Sreenu