This IAF Medical Device Nomenclature document (IAF MDN) is an informative document that was developed for the support of IAF MD8 and MD9. It provides long established medical device names and classifications, where risk classifications do not exist in the Global Medical Device Nomenclature (GMDN).
Within this guide, there are more than 6,000 specific medical device names, divided into 16 categories. The IAF MDN is useful to Accreditation Bodies (ABs) and Conformity Assessment Bodies (CABs), as well as those preparing for an audit or accreditation assessment.
IAF MDN includes multiple risk classifications to help provide a general view of the level of risk of a device. The IAF MDN is clearly an informative document, and is not to be used for determining risk classification for regulatory purposes.