The Medical Devices Introductory Course 2020

Class I (MDR Article 52.7) Non-sterile / Not measuring function / Not reusable surgical instruments

Annex II & Annex III Technical Documentation

Annex XI – Part A Production Quality Assurance

Declaration of Conformity (Annex IV) & CE Marking (Annex V)

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The Organisation for Professionals in Regulatory Affairs

Class I (MDR Article 52.7) Sterile / Measuring function / Reusable surgical instruments

Annex II & Annex III Technical Documentation

NB involved only in aspects related to sterility, metrology or reuse

Annex IX Ch I & Ch III QMS / Admin

Annex XI – Part A Production Quality Assurance

Declaration of Conformity (Annex IV) & CE Marking (Annex V)

1234

The Organisation for Professionals in Regulatory Affairs

14