Our device is referred to IIb class (Rule 10 annex IX) in accordance with MDD 93/42. Some third-party accessories included in the delivery set of our device are referred to class III (Rule 6,7,8) annex IX) in accordance with MDD 93/42. The device is not surgically invasive.
1. Is it possible to refer the system to IIb class, if some of its accessories are referred to III class?
1. Is it possible to refer the system to IIb class, if some of its accessories are referred to III class?