Navigation path


Notification

Found : 24
  Body :

SGS United Kingdom Limited
Unit 202B, Worle Parkway,
Weston-super-Mare, Somerset, BS22 6WA
Country : United Kingdom

Phone : +44 (0)1934 522917
Fax : +44 (0)1934 522137

Email : sgsprodcert@sgs.com
Website : www.uk.sgs.com

Notified Body number : 0120

Version(s): 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18

Last update : 22/01/2013
 

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 update : 18/05/2011                 Version(s): 1 2

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)
EC declaration of conformity (production quality assurance)
Annex IV
Annex VII
 
   - *IVD 0102 - Rhesus (C, c, D, E, e)
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex IV
Annex VII
 
   - *IVD 0103 - Anti-Kell
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex IV
Annex VII
 
*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)
EC declaration of conformity (production quality assurance)
Annex IV
Annex VII
 
   - *IVD 0202 - HTLV I and II
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex IV
Annex VII
 
   - *IVD 0203 - Hepatitis B, C and D
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex IV
Annex VII
 
*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
Full quality assurance system
Production quality assurance
Annex IV
Annex VII
 
   - *IVD 0302 - Irregular anti-erythrocytic antibodies
Full quality assurance system
Production quality assurance
Annex IV
Annex VII
 
   - *IVD 0303 - Congenital infections: rubella, toxoplasmosis
Full quality assurance system
Production quality assurance
Annex IV
Annex VII
 
   - *IVD 0304 - Hereditary disease: phenylketonuria
Full quality assurance system
Production quality assurance
Annex IV
Annex VII
 
   - *IVD 0305 - Human infections: cytomegalovirus, chlamydia
Full quality assurance system
Production quality assurance
Annex IV
Annex VII
 
   - *IVD 0306 - HLA tissue groups: DR, A, B
Full quality assurance system
Production quality assurance
Annex IV
Annex VII
 
   - *IVD 0307 - Tumoral marker: PSA
Full quality assurance system
Production quality assurance
Annex IV
Annex VII
 
   - *IVD 0308 - Risk of trisomy 21 (incl. software)
Full quality assurance system
Production quality assurance
Annex IV
Annex VII
 
   - *IVD 0309 - Device for self-diagnosis: device for the measurement of blood sugar
Full quality assurance system
Production quality assurance
Annex IV
Annex VII
 
*IVD 0400 - Devices for self-testing
 
   - *IVD 0401 - Clinical chemistry
EC declaration of conformity
Full quality assurance system
Production quality assurance
Annex III
Annex IV
Annex VII
 
   - *IVD 0402 - Haematology
EC declaration of conformity
Full quality assurance system
Production quality assurance
Annex III
Annex IV
Annex VII
 
   - *IVD 0403 - Immunology
EC declaration of conformity
Full quality assurance system
Production quality assurance
Annex III
Annex IV
Annex VII
 
   - *IVD 0405 - Pregnancy and ovulation
EC declaration of conformity
Full quality assurance system
Production quality assurance
Annex III
Annex IV
Annex VII
 
   - *IVD 0406 - Specimen receptacles
EC declaration of conformity
Full quality assurance system
Production quality assurance
Annex III
Annex IV
Annex VII
 
 
Horizontal technical competence Limitations
*MDS 7206 - IVDs in sterile condition EC declaration of confirmity Annex III Full quality assurance system Annex IV Production quality assurance Annex VII
*MDS 7207 - IVDs utilising micromechanics EC declaration of confirmity Annex III Full quality assurance system Annex IV Production quality assurance Annex VII
*MDS 7208 - IVDs utilising nanomaterials EC declaration of confirmity Annex III Full quality assurance system Annex IV Production quality assurance Annex VII
*MDS 7209 - IVDs utilising biological active coating and/or material EC declaration of confirmity Annex III Full quality assurance system Annex IV Production quality assurance Annex VII
*MDS 7210 - IVDs utilising material of human origin EC declaration of confirmity Annex III Full quality assurance system Annex IV Production quality assurance Annex VII
Set page to normal font size Increase font size by 200 percentprint this page