active non-implantable devices
for imaging, monitoring and/or
diagnosis
-mda 0201 active non-
implantable imaging devices
utilising 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
-2. active non-implantable
therapeutic devices and general
active non-implantable devices
-mda 0301 active non-
implantable devices utilising
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
page.Věstník 3/2024
44
Products Procedures Articles /Annexes Conditions
-i. codes reFlecting the
design and intended purpose
oF the device
-a. active devices
-2. codes reFlecting the
design and intended purpose
oF the device
-a. active devices
-2. codes reFlecting the
design and intended purpose
oF the device
-a. 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 devices
for imaging, monitoring and/or
diagnosis
-mda 0202 active non-
implantable imaging 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 non-implantable devices
for imaging, monitoring and/or
diagnosis
-mda 0203 active non-
implantable devices for monitoring
of vital physiological parameters
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
-2. active non-implantable devices
for imaging, monitoring and/or
diagnosis
-mda 0204 other active non-
implantable devices for monitoring
and/or diagnosis
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
