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 found that active participation in the standards development processes of the International  Organization for Standardization (ISO), the International Electrotechnical Commission (IEC)  and their corresponding national/mirror committees across RAs is uneven, and resource  constraints, particularly time and people, hinder RA representation


Optimizing Standards for Regulatory Use. International Medical Device Regulators Forum