We have written our clinical evaluation work instructions to comply with MEDDEV 2.7/1 r4.
I'm now trying to figure out how IMDRF/SaMD WG/N41 fits in to all of this.
While the verbiage is different, it appears to refer to the same concepts. What I'm really struggling with is whether I must now require our medical device teams to write a definition statement and be labeled with another category.
The majority of our software devices are class II for FDA and class IIb for CE Mark.
I'm now trying to figure out how IMDRF/SaMD WG/N41 fits in to all of this.
While the verbiage is different, it appears to refer to the same concepts. What I'm really struggling with is whether I must now require our medical device teams to write a definition statement and be labeled with another category.
The majority of our software devices are class II for FDA and class IIb for CE Mark.