Věstník 2/2023
85
product family, product /intended use/product
range
procedure/modules annexes or
articles the
directives
conditions
Conformity assessment based
on product quality assurance
- Non-active non-implantable devices
- MDN 1202 Non-active non-implantable devices for
administration, channelling and removal of
substances, including devices for dialysis
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)
- Non-active non-implantable devices
- MDN 1204 Non-active non-implantable devices for
wound and skin care
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)
- Non-active non-implantable devices
- MDN 1206 Non-active non-implantable
ophthalmologic 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)
- Non-active non-implantable devices
- MDN 1207 Non-active non-implantable diagnostic
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)
- Non-active non-implantable devices
- MDN 1208 Non-active non-implantable
instruments
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)
- Non-active non-implantable devices
- MDN 1209 Non-active non-implantable dental
materials
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)
- Non-active non-implantable devices
- MDN 1210 Non-active non-implantable devices
used for contraception prevention the
transmission sexually transmitted diseases
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)
- Non-active non-implantable devices
- MDN 1211 Non-active non-implantable devices for
disinfecting, cleaning and rinsing
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)
- Non-active non-implantable devices
- MDN 1213 Non-active non-implantable devices
composed substances introduced into the
human body via body orifice the dermal route
Conformity assessment based
on quality management
system
Conformity assessment based
on assessment technical
Annex IX(I)
Annex IX(II)
Annex XI(A)
4
