Arazy Group – Medical Device Consultants
Arazy Group – EU IVD Device Regulation – CE marking – General IVD
Arazy Group – EU IVD Device Regulation – CE mark – Self diagnostic
Arazy Group – Latest news on Medical Devices Regulation

Arazy Group – Relevant Articles about Medical Devices Regulation
If you want to know more about regulatory issues of Medical Devices, click here.
 
 
Arazy Group Home » CE Mark » IVD Mark » Self Diagnostic IVD Devices
 
 
Self Diagnostic IVD Devices
 
CE marking of In-Vitro Self-testing Devices (except for Annex II Devices) meets IVDD 98/79 EEC In-Vitro Diagnostic Medical Devices Directive, Annex III. The provisions for Class General IVD Devices are applicable, plus those included in Annex III – EC Declaration of Conformity according to 98/79 EEC Directive + section 6 – Design Examination by a Notified Body.
In addition to this conformity route, the manufacturer may choose one of the following alternative 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
Arazy Group – EU IVD Device Regulation – CE marking – List A
Arazy Group – Medical Device Regulation - What is CE mark and FDA approval? – FAQs
Arazy Group – Medical Device Regulation – Online Products
 
 
Arazy Group – Medical Device Consultants Arazy Group – Medical Device Consultants Arazy Group – Medical Device Consultants Arazy Group – Medical Device Consultants
2005 Copyright Arazy Group. All rights reserved. | Private Policy