Swiss-EU MRA not updated yet Find a link for the MDCG notice
mdcg_eu-switzerland_mra_en
Agreement regarding EU-Turkey Customs Union for medical devices
MDCG Update_EU-Turkey Customs Union Medical Devices
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 Australia | Therapeutic Goods Administration (TGA)
Launch of the UDI Helpdesk
It provides support on UDI assignment, labelling, registration of devices and also on the use of the European Medical Devices Nomenclature (EMDN). Link: https://eu-udi.zendesk.com/hc/en-150
Bioworld :
published an article entitled “Turbulent times ahead for CE mark with EU’s new MDR soon coming into force”. Link : https://www.bioworld.com/articles/506423-turbulent-times-ahead-for-ce-mark-with-eus-new-mdr-soon-coming-into-force
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 diseases due to COVID-19 15.04.21
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