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List A IVD Devices
 
CE marking of List A In-Vitro Diagnostic Devices included in Annex II meets the IVDD 98/79 EEC In-Vitro Diagnostic Medical Devices Directive following one of the following conformity routes:
  • Annex IV – Full Quality System (ISO 13485:2003) and Notified Body Audit + Annex IV, section 4 – Design Dossier Examination by a Notified Body + Annex VII, section 5 – Product or Batch Verification by a Notified Body.

  • Annex V – EC Type Examination by a Notified Body + Annex VII Production Quality Assurance (ISO 13485:2003 excluding design) and Notified Body Audit and Notified Body Audit + Annex VII, section 5 – Product or Batch Verification by a Notified Body.
 
Arazy Group – EU IVD Device Regulation – CE mark – List B
Arazy Group – EU IVD Device Regulation – CE marking – List A
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