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product family, product /intended use/product
range
procedure/modules annexes or
articles the
directives
conditions
documentation
Conformity assessment based
on product quality assurance
- Non-active non-implantable devices
- MDN 1214 General non-active non-implantable
devices used health care and other non-active
non-implantable 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)
horizontal technical competence conditions
MDS 1001 Devices incorporating medicinal substances
MDS 1004 Devices which are also machinery defined point (a) the second
paragraph Article Directive 2006/42/EC the European Parliament and the
Council (1)
MDS 1005 Devices sterile condition Aseptic processing, ethylene oxide gas
sterilisation (EOG), moist heat sterilisation,
radiation sterilisation (gamma, x-ray, electron
beam)
MDS 1006 Reusable surgical instruments
MDS 1007 Devices incorporating consisting nanomaterial
MDS 1008 Devices utilising biologically active coatings and/or materials being wholly
or mainly absorbed locally dispersed the human body are intended undergo a
chemical change the body
MDS 1009 Devices incorporating software/utilising software/controlled software,
including devices intended for controlling, monitoring directly influencing the
performance active active implantable devices
MDS 1010 Devices with measuring function
MDS 1011 Devices systems procedure packs
MDS 1012 Products without intended medical purpose listed Annex XVI to
Regulation (EU) 2017/745
Excluding products intended totally or
partially introduced into the human body
through surgically invasive means for the
purpose modifying the anatomy fixation
of body parts.g. glass,
ceramics)
MDT 2004 Devices manufactured using non-metal non-mineral processing (e. textiles,
rubber, leather, paper)
MDT 2005 Devices manufactured using biotechnology
MDT 2006 Devices manufactured using chemical processing
MDT 2007 Devices which require knowledge regarding the production of
pharmaceuticals
MDT 2008 Devices manufactured clean rooms and associated controlled
environments
MDT 2009 Devices manufactured using processing materials human, animal, or
microbial origin
including only devices manufactured using
processing materials microbial origin
MDT 2010 Devices manufactured using electronic components including communication
devices
MDT 2011 Devices which require packaging, including labelling
MDT 2012 Devices which require installation, refurbishment
5.
MDT 2001 Devices manufactured using metal processing
MDT 2002 Devices manufactured using plastic processing
MDT 2003 Devices manufactured using non-metal mineral processing (e. Excluding equipment intended
to used reduce, remove destroy
adipose tissue, such equipment for
liposuction, lipolysis lipoplasty
