Regulatory Affairs

The Regulatory Affairs Sector is a key pillar of technical documentation and institutional dialogue of SEIV on matters concerning the regulatory framework of medical devices and in vitro diagnostics.

The significant changes introduced by the European Regulations MDR and IVDR create new challenges for businesses, competent authorities, and the healthcare system.

The Sector contributes to:

• monitoring regulatory developments
• recording practical issues related to the implementation of legislation
• formulating well-documented positions addressed to the competent authorities
• strengthening institutional dialogue with the relevant authorities

At the same time, it supports member companies in adapting to the new regulatory environment, promoting patient safety and the sustainable development of the sector.