Notification Of A Body In The Framework Of Technical

notification of a body in the framework of technical harmonization directive reference directive: 98/79/ec in vitro diagnostic medical

Notification of a Body in the framework of technical harmonization
directive
Reference
Directive: 98/79/EC in vitro diagnostic medical devices
From
To
 
European Commission
Enterprise Directorate-General
-
B 1049 Brussels
and to other Member States
and to other Member States
Name of the Designating Authority
Competence assessment performed by
==================================
 
 
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
 
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
1Annexes
2Limitations
IVD 0100
List A: Reagents and reagent products, including related calibrators
and control materials, for determining the following blood groups
III
IV
V
VI
VII
IVD 0101
AB0 system
 
 
 
 
 
 
IVD 0102
Rhesus (C, c, D, E, e)
 
 
 
 
 
 
IVD 0103
Anti-Kell
 
 
 
 
 
 
IVD 0200
List A: Reagents and reagent products, including related calibrators
and control materials, for the detection, confirmation and
quantification in human specimens of markers of
III
IV
V
VI
VII
IVD 0201
HIV infection (HIV 1 and 2)
 
 
 
 
 
 
IVD 0202
HTLV I and II
 
 
 
 
 
 
IVD 0203
Hepatitis B, C and D
 
 
 
 
 
 
IVD 0204
Variant Creutzfeldt-Jakob disease (vCJD)
 
 
 
 
 
 
IVD 0300
List B: Reagents, reagent products and devices for self - diagnosis,
including related calibrators and control materials, for determining,
detection, quantification, diagnosing, evaluating
III
IV
V
VI
VII
IVD 0301
Anti-Duffy and anti-Kidd
 
 
 
 
 
 
IVD 0302
Irregular anti-erythrocytic antibodies
 
 
 
 
 
 
IVD 0303
Congenital infections: rubella, toxoplasmosis
 
 
 
 
 
 
IVD 0304
Hereditary disease: phenylketonuria
 
 
 
 
 
 
IVD 0305
Human infections: cytomegalovirus, chlamydia
 
 
 
 
 
 
IVD 0306
HLA tissue groups: DR, A, B
 
 
 
 
 
 
IVD 0307
Tumoral marker: PSA
 
 
 
 
 
 
IVD 0308
Risk of trisomy 21 (incl. software)
 
 
 
 
 
 
IVD 0309
Device for self-diagnosis: device for the measurement of blood sugar
 
 
 
 
 
 
Code
IVD scope expressions
1Annexes
2Limitations
IVD 0400
Devices for self-testing
III
IV
V
VI
VII
IVD 0401
Clinical chemistry
 
 
 
 
 
 
IVD 0402
Haematology
 
 
 
 
 
 
IVD 0403
Immunology
 
 
 
 
 
 
IVD 0404
Molecular biology
 
 
 
 
 
 
IVD 0405
Pregnancy and ovulation
 
 
 
 
 
 
IVD 0406
Specimen receptacles
 
 
 
 
 
 
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
1Select
2Limitations
MDS 7200
IVD Specifics
MDS 7205
IVDs incorporating software / utilising software / controlled by
software
 
 
MDS 7206
IVDs in sterile condition
 
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)
MDS 7207
IVDs utilising micromechanics
 
 
MDS 7208
IVDs utilising nanomaterials
 
 
MDS 7209
IVDs utilising biological active coating and/or material
 
 
MDS 7210
IVDs utilising material of human origin
 
 
NBOG F 2012-3
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