Here is a table to help you identify if your device is under the definition of Reusable Surgical Instrument (and thus would require the involvement…
Posts published in October 2019
The Commission concluded that it will only be possible to make EUDAMED operational once the entire system and its different modules have achieved full functionality…
TGA presentation: Cybersecurity for medical devices
TGA presentation: How to submit an effective good manufacturing practice clearance application
TGA-led IMDRF Personalised Medical Devices working group meets in Canberra
Ear, Nose, and Throat Devices; Classification of the Self-Fitting Air-Conduction Hearing Aid
Second NB under the IVDR notified – BSI UK notified under the IVDR
Ongoing Guidance development within MDCG Subgroups