S
Hi all,
I am very confused with the conformity assessment options in the MDR. Our device is non-medical under MDD but will become medical (class IIb) under new MDR regulation. I've been reading the conformity assessment options for the past 2 days and still can't figure out- what is the difference between annex IX and annexes X-XI? Both require QMS and technical documentation, audit by NB, etc.
I am very confused with the conformity assessment options in the MDR. Our device is non-medical under MDD but will become medical (class IIb) under new MDR regulation. I've been reading the conformity assessment options for the past 2 days and still can't figure out- what is the difference between annex IX and annexes X-XI? Both require QMS and technical documentation, audit by NB, etc.