
Understanding EUDAMED and Its Impact on Medical Device Compliance
EUDAMED (European Database on Medical Devices) is an essential information system for the European Union’s regulatory framework for medical devices.
EUDAMED (European Database on Medical Devices) is an essential information system for the European Union’s regulatory framework for medical devices.
In the highly regulated world of medical devices and in vitro diagnostics (IVDs), ensuring compliance with international standards is critical for market access and patient safety.
The Therapeutic Goods Administration (TGA), the Australian authority responsible for medical device regulation, has published detailed guidance describing the documentation to be submitted by the applicant in the context of inclusion of a medical device to the...