Document paper New medtech regulations

MedTech Europe welcomes the adoption of the Substances of Human Origin Regulation

MedTech Europe welcomes the final adoption of the Substances of Human Origin (SoHO) Regulation by the Council of the EU.

This achievement marks a significant milestone in advancing the safety and quality standards of blood, tissues and cells across Europe.

We underline the importance of aligning this piece of legislation with other interconnected requirements from Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices, Regulation (EU) 2017/745 on Medical Devices, and Regulation (EC) No 1907/2006 (REACH).

Posted on 23.05.2024

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