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First Revision Of EU Medtech Standardization Mandate Due Early 2023

 
• By Amanda Maxwell

Work is progressing towards publications of an updated list of standards to support implementation of the EU’s new medtech regulations.  

Blue arrows against a blue-sky background, with the word "Standards" written on one.

The revised EU mandate for standards that are required in the context of the Medical Device and IVD Regulations is currently under official review. The commission hopes it will be published in early 2023.

This will be the first amendment to the European Commission mandate for the development of harmonized medtech standards. The original mandate was accepted by the EU standards organizations, CEN and Cenelec, in the context of the MDR and IVDR in May 2021

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