NBOG F 2012-1
Notification of a Body in the framework of technical harmonization directive
Reference
Directive: 93/42/EEC Medical devices
From
To
Name of the Designating Authority
Competence assessment performed by
European Commission
Enterprise Directorate-General
B 1049 Brussels
and to other Member States
Body name, address, telephone, fax, email, website
Identification number of the body
Basis of competence assessment
Notification date
Created or last update
Period of validity of the notification
NBOG F 2012-1
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Page 1 of 5
1.
Medical devices, non-active, 93/42/EEC, competence for the selected product(s) and procedure(s)
1Mark
selected products and procedures with a cross (x) in the gray boxes.
Annex II: Full quality assurance system; Annex III: EC type-examination; Annex IV: EC verification;
Annex V: Production quality assurance; Annex VI: Product quality assurance
2Specify
MD 0000
MD 0100
MD 0101
MD 0102
MD 0103
MD 0104
MD 0105
MD 0106
MD 0107
MD 0108
MD 0109
MD 0110
MD 0200
MD 0201
MD 0202
MD 0203
MD 0204
MD 0300
MD 0301
MD 0302
MD 0303
limitations (Annexes and/or products) where applicable
Medical Devices, Non-Active
General non-active, non-implantable
medical devices
Non-active devices for anaesthesia,
emergency and intensive care
Non-active devices for injection, infusion,
transfusion and dialysis
Non-active orthopaedic and rehabilitation
devices
Non-active medical devices with measuring
function
Non-active ophthalmologic devices
Non-active instruments
Contraceptive medical devices
Non-active medical devices for disinfecting,
cleaning, rinsing
Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies
(ART)
Non-active medical devices for ingestion
Non-active implants
Non-active cardiovascular implants
Non-active orthopaedic implants
Non-active functional implants
Non-active soft tissue implants
Devices for wound care
Bandages and wound dressings
Suture material and clamps
Other medical devices for wound care
NBOG F 2012-1
1
2
Annexes
Limitations
II
III
IV
V
VI
II
III
IV
V
VI
II
III
IV
V
VI
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Page 2 of 5
MD 0000
MD 0400
MD 0401
MD 0402
MD 0403
2.
Medical Devices, Non-Active
Non-active dental devices and
accessories
Non-active dental equipment and
instruments
Dental materials
Dental implants
1
Annexes
II
III
2
Limitations
IV
V
VI
Medical devices, active, 93/42/EEC, competence for the selected product(s) and procedure(s)
1Mark
selected products and procedures with a cross (x) in the gray boxes.
Annex II: Full quality assurance system; Annex III: EC type-examination; Annex IV: EC verification;
Annex V: Production quality assurance; Annex VI: Product quality assurance
2Specify
MD 1000
MD 1100
MD 1101
MD 1102
MD 1103
MD 1104
MD 1105
MD 1106
MD 1107
MD 1108
MD 1109
MD 1110
MD 1111
MD 1112
limitations (Annexes and/or products) where applicable
Medical Devices, Active
General active medical devices
Devices for extra-corporal circulation,
infusion and haemopheresis
Respiratory devices, devices including
hyperbaric chambers for oxygen therapy,
inhalation anaesthesia
Devices for stimulation or inhibition
Active surgical devices
Active ophthalmologic devices
Active dental devices
Active devices for disinfection and
sterilisation
Active rehabilitation devices and active
prostheses
Active devices for patient positioning and
transport
Active devices for in vitro fertilisation (IVF)
and assisted reproductive technologies
(ART)
Software
Medical gas supply systems and parts
thereof
NBOG F 2012-1
1
Annexes
II
III
2
Limitations
IV
V
-
VI
Page 3 of 5
MD 1000
MD 1200
MD 1201
MD 1202
MD 1300
MD 1301
MD 1302
MD 1400
MD 1401
MD 1402
MD 1403
MD 1404
3.
Medical Devices, Active
Devices for imaging
Imaging devices utilising ionizing radiation
Imaging devices utilising non-ionizing
radiation
Monitoring devices
Monitoring devices of non-vital physiological
parameters
Monitoring devices of vital physiological
parameters
Devices for radiation therapy and thermo
therapy
Devices utilising ionizing radiation
Devices utilising non-ionizing radiation
Devices for hyperthermia / hypothermia
Devices for (extracorporal) shock-wave
therapy (lithotripsy)
1
Annexes
II
III
2
Limitations
IV
V
VI
II
III
IV
V
VI
II
III
IV
V
VI
Medical devices, 93/42/EEC, competence for the selected specifics
1Mark
selected specifics with a cross (x) in the gray boxes.
limitations, when they are applicable. Without any limitation, each specific item is applicable to the chosen scopes under MD 0000 and MD 1000.
2Specify
MDS 7000
MDS 7001
MDS 7002
MDS 7003
MDS 7004
MDS 7005
MDS 7006
1
1
Specifics of Medical Devices
Medical devices incorporating medicinal substances, according to
Directive 2001/83/EC
Medical devices utilising tissues of animal origin, including
Commission Regulation (EU) No 722/20121
Medical devices incorporating derivates of human blood, according to
Directive 2000/70/EC, amended by Directive 2001/104/EC
Medical devices referencing the Directive 2006/42/EC on machinery
(currently not used)
Medical devices in sterile condition
Select
2
Limitations
Including aseptic processing, ethylene oxide gas sterilisation
(EOG), low temperature steam and formaldehyde sterilisation,
moist heat sterilisation, radiation sterilisation (gamma, x-ray,
electron beam), others (need to be specified)
Until 28 August 2013 Directive 2003/32/EC
NBOG F 2012-1
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Page 4 of 5
MDS 7000
MDS 7007
MDS 7008
MDS 7009
MDS 7010
1
Specifics of Medical Devices
Medical devices utilising micromechanics
Medical devices utilising nanomaterials
Medical devices utilising biological active coatings and/or materials or
being wholly or mainly absorbed
Medical devices incorporating software / utilising software / controlled
by software
NBOG F 2012-1
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Select
2
Limitations
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