non-active devices
-2. codes reFlecting the
design and intended purpose
oF the device
-b.Věstník 3/2024
47
Products Procedures Articles /Annexes Conditions
-i. non-active non-implantable
devices
-mdn 1208 non-active non-
implantable instruments
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. non-active non-implantable
devices
-mdn 1209 non-active non-
implantable 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. non-active non-implantable
devices
-mdn 1214 general non-active
non-implantable devices used in
health care and other non-active
non-implantable 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,
only devices
intended for
Horizontal technical competences Limitations
mds 1004 devices which are also machinery as
defined point (a) the second paragraph article of
directive 2006/42/ec the european parliament and of
the council (1):
mds 1005 devices sterile condition: assesptic processing, ethylene oxid gas sterilisantion
(EOG), moist heat sterilisation, radiation sterilisation (only
gamma), thermic sterilisation with dry heat
mds 1006 reusable surgical instruments:
mds 1007 devices incorporating consisting of
nanomaterial:
mds 1009 devices incorporating software/utilising
software/controlled software, including devices
intended for controlling, monitoring directly influencing
the performance active active implantable devices:
page. codes reFlecting the
design and intended purpose
oF the device
-b. non-active non-implantable
devices
-mdn 1211 non-active non-
implantable devices for
disinfecting, cleaning and rinsing
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. codes reFlecting the
design and intended purpose
oF the device
-b. non-active devices
-2. non-active devices
-2
