Hi everyone,
I was talking to a regulatory consultant earlier today and we brushed on the topic of the PSUR. She informed me that she had been advised that the PSUR isn't required for your first submission for the MDR and the CER will cover the data you would need as part of the PSUR. You will need to carry out the PSUR thereafter to be compliant, of course.
Is this assertion correct or do you still need a PSUR with your first submission of the technical file under MDR?
I was talking to a regulatory consultant earlier today and we brushed on the topic of the PSUR. She informed me that she had been advised that the PSUR isn't required for your first submission for the MDR and the CER will cover the data you would need as part of the PSUR. You will need to carry out the PSUR thereafter to be compliant, of course.
Is this assertion correct or do you still need a PSUR with your first submission of the technical file under MDR?