June 2021
Remote Audits survey analysis
A very significant survey thanks to the answers of 46 [...]
JAMS report available
On the CAMD website: https://www.camd-europe.eu/regulatory/the-jams-laymans-report-is-now-available-online/
May 2021
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 [...]
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 [...]