Module 19: Regulation of In Vitro Diagnostic Medical Devices

28/03/2023

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How to write a DoC (declaration of conformity)

The Organisation for Professionals in Regulatory Affairs

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EU declaration of conformity (IVDR Article 17.1)

“1. … The manufacturer shall continuously update the EU declaration of conformity. The EU declaration of conformity shall, as a minimum, contain the information set out in Annex IV and shall be translated into an official Union language or languages required by the Member State(s) in which the device is made available.“

The Organisation for Professionals in Regulatory Affairs

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