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List B IVD Devices
 
CE marking of List B 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 V – EC Type Examination by a Notified Body + Annex VII Production Quality Assurance (ISO 13485:2003 excluding design) and Notified Body Audit.

  • Annex V – EC Type Examination by a Notified Body + Annex VI – EC Product Verification by a Notified Body
 
Arazy Group – EU IVD Device Regulation – CE mark – List B
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