May 2021
Team-NB members adopted a Position Paper with considerations on conformity assessment for class D devices thanks to the work of the IVD working group.
Team-NB-PositionPaper-ClassD-20210519-V4.4
EU Medical Device Regulation: Implications for the TGA and Australia. Link for Presentation
Presentation: EU Medical Device Regulation: Implications for the TGA and [...]
Launch of the UDI Helpdesk
It provides support on UDI assignment, labelling, registration of devices [...]
Bioworld :
published an article entitled “Turbulent times ahead for CE mark [...]
April 2021
European Biosafety Network published guidance on Sharps injuries. Team-NB is involved and is committed to reaching a better level of safety in using medical devices and working towards developing a standard.
Europe must act now to stop the spread of deadly [...]
The CORE-project funded by EU has started today for 36 months period addressing ‘’EU assessment of high-risk medical devices faces in-depth review’’.
CORE-MD_press_release_ 13April 2021_FINAL
On May 7th, the Commission is organising a webinar on MDR for patients.
To register for the webinar please follow this link: :http://attendee.gotowebinar.com/register/406747148666469135 [...]