CE marked IVD - Does the "IVD" symbols needs to be in the IFUs?

[ernieto]

For a CE marked IVD, does the "IVD" symbols needs to be in the IFUs?

 

[pkost]

re: CE marked IVD - Does the "IVD" symbols needs to be in the IFUs?

er 8.7 details the requirements for the IFU. Part A says to include " the details referred to in section 8.4 with the exception of points (d) and (e)"

it is this part (8.4g) that requires the symbol indicating IVD in the IFU

so....yes

 

[ernieto]

Thanks