Standards play a significant role in the design, production, post-production and regulation of medical devices throughout their lifecycle. Important tools for conformity assessment, standards facilitate and support innovation and help ensure that devices are safe and perform as intended.
Standards offer a means to streamline and harmonize regulatory processes around the world, especially as medical devices grow in complexity and international markets expand.
In preparing this guidance, IMDRF learned that while all its member regions use standards for regulatory purposes, they differ in how they apply and/or recognize them. In addition, IMDRF’s research found that RAs’ active participation in the standards development processes of two international SDOs, the International Organization for Standardization (ISO), the International Electrotechnical Commission (IEC) as well as their corresponding national/mirror committees is uneven, and resource constraints, particularly time and people, hinder a robust and effective RA representation