Publicly available resources provided by our partner Market Access (AUS)

EU Authorised Representative services

Market Access (AUS) newsletters and other useful information

EU new regulations for medical devices and in vitro diagnostic medical devices

EU MDCG endorsed documents and other guidance

EU Factsheet for Authorised Representatives, Importers and Distributors of medical devices and IVDs (01/08/2020)

EUDAMED database

TGA strategy of aligning the Australian medical device with EU MDR, IMDRF and U.S. FDA