Věstník 2/2023
84
product family, product /intended use/product
range
procedure/modules annexes or
articles the
directives
conditions
- Active non-implantable therapeutic devices and
general active non-implantable devices
- MDA 0309 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)
- Active non-implantable therapeutic devices and
general active non-implantable devices
- MDA 0312 Other active non-implantable surgical
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)
- Active non-implantable therapeutic devices and
general active non-implantable devices
- MDA 0315 Software
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 0316 Medical gas supply systems and parts
thereof
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 0317 Active non-implantable devices for
cleaning, disinfection and sterilisation
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 devices
- Non-active implants and long term surgically
invasive devices
- MDN 1102 Non-active osteo- and orthopaedic
implants
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 implants and long term surgically
invasive devices
- MDN 1103 Non-active dental implants and 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 implants and long term surgically
invasive devices
- MDN 1104 Non-active soft tissue and other
implants
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)
Excluding IUD, breast
implants and
non-absorbable dermal
fillers based on
methylmethacrylate nad
silicones
- Non-active non-implantable devices
- MDN 1201 Non-active non-implantable devices for
anaesthesia, emergency and intensive care
Conformity assessment based
on quality management
system
Conformity assessment based
on assessment technical
documentation
Annex IX(I)
Annex IX(II)
Annex XI(A)
3
