active non-implantable
therapeutic devices and general
active non-implantable devices
-mda 0315 software
Conformity assessment based quality
management system
Conformity assessment based on
assessment technical documentation
Conformity assessment based product
quality assurance
Annex IX(I)
Annex IX(II)
Annex XI(A)
except IIIrd class
devices, annex XI
(A) only Is, Im, Ir,
IIa class devices
page. codes reFlecting the
design and intended purpose
oF the device
-a. active non-implantable
therapeutic devices and general
active non-implantable devices
-mda 0307 active non-
implantable respiratory devices
Conformity assessment based quality
management system
Conformity assessment based on
assessment technical documentation
Conformity assessment based product
quality assurance
Annex IX(I)
Annex IX(II)
Annex XI(A)
except IIIrd class
devices, annex XI
(A) only Is, Im, Ir,
IIa class devices
-i. active devices
-3. codes reFlecting the
design and intended purpose
oF the device
-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 quality
management system
Conformity assessment based on
assessment technical documentation
Conformity assessment based product
quality assurance
Annex IX(I)
Annex IX(II)
Annex XI(A)
except IIIrd class
devices, annex XI
(A) only Is, Im, Ir,
IIa class devices
-i. active devices
-3. active devices
-3.Věstník 3/2024
45
Products Procedures Articles /Annexes Conditions
-i. codes reFlecting the
design and intended purpose
oF the device
-a. active devices
-3. codes reFlecting the
design and intended purpose
oF the device
-a. codes reFlecting the
design and intended purpose
oF the device
-a. active non-implantable
therapeutic devices and general
active non-implantable devices
-mda 0312 other active non-
implantable surgical devices
Conformity assessment based quality
management system
Conformity assessment based on
assessment technical documentation
Conformity assessment based product
quality assurance
Annex IX(I)
Annex IX(II)
Annex XI(A)
except IIIrd class
devices, annex XI
(A) only Is, Im, Ir,
IIa class devices
-i. active non-implantable
therapeutic devices and general
active non-implantable devices
-mda 0305 active non-
implantable devices for stimulation
or inhibition
Conformity assessment based quality
management system
Conformity assessment based on
assessment technical documentation
Conformity assessment based product
quality assurance
Annex IX(I)
Annex IX(II)
Annex XI(A)
except IIIrd class
devices, annex XI
(A) only Is, Im, Ir,
IIa class devices
-i. active devices
-3
