Reclassification of medical devices that administer medicines or biologicals by inhalation

This guidance aims to assist sponsors of medical devices that administer medicines or biologicals by inhalation with meeting their obligations and outlines transitional arrangements to help comply with new regulations.

From 25 November 2021 medical devices that administer medicines or biologicals by inhalation will be required to meet regulatory requirements demonstrating the safety and efficacy of the product commensurate with the higher classification (Class IIa or Class IIb).