Don’t worry about changing your EU Authorized Representative! The process became much more formal, but not complicated. We guide you through.
Change process under the MDR / IVDR
Under the Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), the process of changing your EU Authorized Representative becomes much more formal.
Article 12 of the MDR and IVDR suggest an agreement between the manufacturer, the outgoing Authorized Representative and the incoming Authorized Representative.
The agreement should at least cover the aspects below.
- Date of termination/ beginning of the outgoing/ incoming Authorized Representative’s mandates,
- Date until which the outgoing Authorized Representative will appear on the labeling,
- Transfer of documents,
- Obligation of the outgoing Authorized Representative to inform the manufacturer or incoming Authorized Representative about any suspected incidents related to products the outgoing Authorized Representative has been mandated before.
Do you have any doubts or questions related to these provisions? Please don’t hesitate to get in touch with us!