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As the association representing the medical technology sector, MedTech Europe welcomes the recognition in the inception impact assessment that pharma health solutions bring about technological advances, and the inclusion of the potential of the digital transformation of health and care.

Introduction The Alliance Promotion Microbiote (APM) is an independent non-profit organization gathering more than 20 key players from microbiome public and private sectors (biotech companies, CDMO, public research institutes and clusters, investment funds etc.) with the objective to contribute to a favorable environment to develop microbiome promising sector.

MedTech Europe - the European trade association for the medical technology industry including diagnostics, medical devices and digital health - welcomes the opportunity to contribute to the initial consultation regarding the revision of the Union legislation on blood, tissues and cells.

Introduction We acknowledge the European Commission’s proposal on standards of quality and safety for Substances of Human Origin (SoHO) for human application and welcomes the opportunity to participate to this consultation.

MedTech Europe welcomes the Proposal for a Regulation on substances of human origin adopted by the European Commission in July 2022. We agree that the sector needs updated legislation, and the proposed text reinforces the rules for safety and quality. We are looking forward patients to having smooth access to products, the availability of which is uninterrupted on the European market.