European Commission - Growth

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Notification

Found : 26
 
  Body :

BSI Group The Netherlands B.V.
Say Building, John M. Keynesplein 9, 1066 EP
Amsterdam
Country : Netherlands

Phone : +31 (0)20 346 07 80
Fax : -

Email : info.nl@bsigroup.com
Website : www.bsigroup.com

Notified Body number : 2797

Version(s): 1 2 3 4 5

Last approval date : 27/11/2020
 

Return to legislation list

Some information about the accreditation details are available in the PDF
Legislation
98/79/EC In vitro diagnostic medical devices    
Last approval date : 01/12/2018
Products Procedures Articles/Annexes Limitations
*IVD 0100 - Reagents and reagent products, including related calibrators and control materials, for determining the following blood groups
 
   - *IVD 0101 - ABO system
EC declaration of conformity (full quality assurance system) Annex IV  
   - *IVD 0102 - Rhesus (C, c, D, E, e)
EC declaration of conformity (full quality assurance system) Annex IV  
   - *IVD 0103 - Anti-Kell
EC declaration of conformity (full quality assurance system) Annex IV  
*IVD 0200 - Reagents and reagent products, including related calibrators and control materials, for the detection, confirmation and quantification in human specimens of markers of
 
   - *IVD 0201 - HIV infection (HIV 1 and 2)
EC declaration of conformity (full quality assurance system) Annex IV  
   - *IVD 0202 - HTLV I and II
EC declaration of conformity (full quality assurance system) Annex IV  
   - *IVD 0203 - Hepatitis B, C and D
EC declaration of conformity (full quality assurance system) Annex IV  
   - *IVD 0204 - Variant Creutzfeldt-Jakob disease (vCJD)
EC declaration of conformity (full quality assurance system) Annex IV  
*IVD 0300 - Reagents, reagent products and devices for self-diagnosis, including related calibrators and control materials, for determining, detection, quantification, diagnosing, evaluating
 
   - *IVD 0301 - Anti-Duffy and anti-Kidd
EC declaration of conformity (full quality assurance system) Annex IV  
   - *IVD 0302 - Irregular anti-erythrocytic antibodies
EC declaration of conformity (full quality assurance system) Annex IV  
   - *IVD 0303 - Congenital infections: rubella, toxoplasmosis
EC declaration of conformity (full quality assurance system) Annex IV  
   - *IVD 0304 - Hereditary disease: phenylketonuria
EC declaration of conformity (full quality assurance system) Annex IV  
   - *IVD 0305 - Human infections: cytomegalovirus, chlamydia
EC declaration of conformity (full quality assurance system) Annex IV  
   - *IVD 0306 - HLA tissue groups: DR, A, B
EC declaration of conformity (full quality assurance system) Annex IV  
   - *IVD 0307 - Tumoral marker: PSA
EC declaration of conformity (full quality assurance system) Annex IV  
   - *IVD 0308 - Risk of trisomy 21 (incl. software)
EC declaration of conformity (full quality assurance system) Annex IV  
   - *IVD 0309 - Device for self-diagnosis: device for the measurement of blood sugar
EC declaration of conformity (full quality assurance system) Annex IV  
*IVD 0400 - Devices for self-testing
 
   - *IVD 0401 - Clinical chemistry
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
Annex III
Annex IV
 
   - *IVD 0402 - Haematology
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
Annex III
Annex IV
 
   - *IVD 0403 - Immunology
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
Annex III
Annex IV
 
   - *IVD 0404 - Molecular biology
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
Annex III
Annex IV
 
   - *IVD 0405 - Pregnancy and ovulation
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
Annex III
Annex IV
 
   - *IVD 0406 - Specimen receptacles
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
Annex III
Annex IV
 
 
Horizontal technical competence Limitations
*MDS 7205 - IVDs incorporating software / utilising software / controlled by software  
*MDS 7206 - IVDs in sterile condition  
*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