Věstník 2/2023
83
tasks performed the body :
last approval date 29/11/2022
product family, product /intended use/product
range
procedure/modules annexes or
articles the
directives
conditions
I. CODES REFLECTING THE DESIGN AND
INTENDED PURPOSE THE DEVICE
- Active devices
- Active non-implantable devices for imaging,
monitoring and/or diagnosis
- MDA 0201 Active non-implantable imaging devices
utilising ionizing radiation
Conformity assessment based
on quality management
system
Conformity assessment based
on assessment technical
documentation
Conformity assessment based
on product quality assurance
Annex IX(I)
Annex IX(II)
Annex XI(A)
- Active non-implantable devices for imaging,
monitoring and/or diagnosis
- MDA 0202 Active non-implantable imaging devices
utilising non-ionizing radiation
Conformity assessment based
on quality management
system
Conformity assessment based
on assessment technical
documentation
Conformity assessment based
on product quality assurance
Annex IX(I)
Annex IX(II)
Annex XI(A)
- Active non-implantable devices for imaging,
monitoring and/or diagnosis
- MDA 0203 Active non-implantable devices for
monitoring vital physiological parameters
Conformity assessment based
on quality management
system
Conformity assessment based
on assessment technical
documentation
Conformity assessment based
on product quality assurance
Annex IX(I)
Annex IX(II)
Annex XI(A)
- Active non-implantable therapeutic devices and
general active non-implantable devices
- MDA 0302 Active non-implantable devices utilising
non-ionizing radiation
Conformity assessment based
on quality management
system
Conformity assessment based
on assessment technical
documentation
Conformity assessment based
on product quality assurance
Annex IX(I)
Annex IX(II)
Annex XI(A)
- Active non-implantable therapeutic devices and
general active non-implantable devices
- MDA 0303 Active non-implantable devices utilising
hyperthermia/hypothermia
Conformity assessment based
on quality management
system
Conformity assessment based
on assessment technical
documentation
Conformity assessment based
on product quality assurance
Annex IX(I)
Annex IX(II)
Annex XI(A)
- Active non-implantable therapeutic devices and
general active non-implantable devices
- MDA 0305 Active non-implantable devices for
stimulation inhibition
Conformity assessment based
on quality management
system
Conformity assessment based
on assessment technical
documentation
Conformity assessment based
on product quality assurance
Annex IX(I)
Annex IX(II)
Annex XI(A)
- Active non-implantable therapeutic devices and
general active non-implantable devices
- MDA 0306 Active non-implantable devices for
extra-corporal circulation, administration removal
of substances and haemapheresis
Conformity assessment based
on quality management
system
Conformity assessment based
on assessment technical
documentation
Conformity assessment based
on product quality assurance
Annex IX(I)
Annex IX(II)
Annex XI(A)
- Active non-implantable therapeutic devices and
general active non-implantable devices
- MDA 0307 Active non-implantable respiratory
devices
Conformity assessment based
on quality management
system
Conformity assessment based
on assessment technical
documentation
Conformity assessment based
on product quality assurance
Annex IX(I)
Annex IX(II)
Annex XI(A)
2
