Extending the deadlines for the implementation of the new IVDR

Dear customers,

we would like to share with you the great news on the decision of the European Commission (14 Oct 2021) extending the deadlines for the implementation of the new IVDR (Regulation No. 2017/746) in order to avoid disruption of the supply of in vitro medical devices.

According to the risk classes of IVD devices, the new terms are proposed according to the following table: 

 
END of Transition period For Compliance with IVDR  
Risk Class Deadline
Class D 26 May 2025
Class C 26 May 2026
Class B 26 May 2027
Class A devices placed on the market in a sterile condition 26 May 2027
 
 

For more information, please use links to EU official announcement:

In Vitro Diagnostic Medical Devices Regulation (europa.eu)
md_2017-746-regulation_2021-amendment_en.pdf (europa.eu)