NBOG F 2012-3
Notification of a Body in the framework of technical harmonization directive
Reference
Directive: 98/79/EC in vitro diagnostic 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
and to other Member States
Identification number of the body
Basis of competence assessment
Notification date
Created or last update
Period of validity of the notification
NBOG F 2012-3
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1. In vitro diagnostic medical devices, 98/79/EC, competence for the selected product(s) and procedure(s)
1Mark
selected products and procedures with a cross (x) in the gray boxes.
Annex III: EC declaration of conformity; Annex IV: Full quality assurance system; Annex V: EC type-examination;
Annex VI: EC verification; Annex VII: Production quality assurance
2Specify limitations where applicable
CODE
IVD SCOPE EXPRESSIONS
IVD 0100
List A: Reagents and reagent products,
including related calibrators and control
materials, for determining the following blood
groups
AB0 system
Rhesus (C, c, D, E, e)
Anti-Kell
List A: Reagents and reagent products,
including related calibrators and control
materials, for the detection, confirmation and
quantification in human specimens of
markers of
HIV infection (HIV 1 and 2)
HTLV I and II
Hepatitis B, C and D
Variant Creutzfeldt-Jakob disease (vCJD)
List B: Reagents, reagent products and
devices for self - diagnosis, including related
calibrators and control materials, for
determining, detection, quantification,
diagnosing, evaluating
Anti-Duffy and anti-Kidd
Irregular anti-erythrocytic antibodies
Congenital infections: rubella, toxoplasmosis
Hereditary disease: phenylketonuria
Human infections: cytomegalovirus,
chlamydia
HLA tissue groups: DR, A, B
Tumoral marker: PSA
Risk of trisomy 21 (incl. software)
Device for self-diagnosis: device for the
measurement of blood sugar
IVD 0101
IVD 0102
IVD 0103
IVD 0200
IVD 0201
IVD 0202
IVD 0203
IVD 0204
IVD 0300
IVD 0301
IVD 0302
IVD 0303
IVD 0304
IVD 0305
IVD 0306
IVD 0307
IVD 0308
IVD 0309
NBOG F 2012-3
1
2
ANNEXES
LIMITATIONS
III
IV
V
VI
VII
III
IV
V
VI
VII
III
IV
V
VI
VII
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CODE
IVD SCOPE EXPRESSIONS
IVD 0400
IVD 0401
IVD 0402
IVD 0403
IVD 0404
IVD 0405
IVD 0406
Devices for self-testing
Clinical chemistry
Haematology
Immunology
Molecular biology
Pregnancy and ovulation
Specimen receptacles
1
2
ANNEXES
III
LIMITATIONS
IV
V
VI
VII
2. In vitro diagnostic medical devices, 98/79/EC, competence for the selected specifics
1Mark
selected specifics with a cross (x) in the gray boxes.
2Specify
limitations when they are applicable. Without any limitation, each specific item is applicable to the chosen IVD scopes.
CODE
IVD SCOPE EXPRESSIONS, ADDITIONS
MDS 7200
MDS 7205
MDS 7206
IVD Specifics
IVDs incorporating software / utilising software / controlled
by software
IVDs in sterile condition
MDS 7207
MDS 7208
MDS 7209
MDS 7210
IVDs utilising micromechanics
IVDs utilising nanomaterials
IVDs utilising biological active coating and/or material
IVDs utilising material of human origin
NBOG F 2012-3
1
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)
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