Věstník 3/2024
46
Products Procedures Articles /Annexes Conditions
-i. active devices
-3. non-active non-implantable
devices
-mdn 1205 non-active non-
implantable orthopaedic and
rehabilitation 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. codes reFlecting the
design and intended purpose
oF the device
-a. codes reFlecting the
design and intended purpose
oF the device
-b. non-active devices
-1. non-active implants and long
term surgically invasive devices
-mdn 1102 non-active osteo-
and orthopaedic implants
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. non-active devices
-2. 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 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. non-active non-implantable
devices
-mdn 1207 non-active non-
implantable diagnostic 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
page. active devices
-3. codes reFlecting the
design and intended purpose
oF the device
-a. codes reFlecting the
design and intended purpose
oF the device
-b. non-active devices
-1. non-active devices
-2. codes reFlecting the
design and intended purpose
oF the device
-b. active non-implantable
therapeutic devices and general
active non-implantable devices
-mda 0316 medical gas
supply systems and parts thereof
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. non-active implants and long
term surgically invasive devices
-mdn 1103 non-active dental
implants and dental materials
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. codes reFlecting the
design and intended purpose
oF the device
-b
