Call for experts – Harmonised standards
All the information and contact are available on https://app.gignow.com/ey/job_postings/6a654c78d8bb442897d756e9d832b215.
SIDIV
Team-NB representative operates a session on the implementation of the new IVD regulation organised by SIDIV for its members
A webinar on Sharps and MDR is organised by EBN
Team-NB has been invited to speak at this webinar (agenda attached)Agenda for webinar on sharps injuries and the MDR 08.06.21
Remote Audits survey analysis
A very significant survey thanks to the answers of 46 NBs (on 52 designated).CIRCABC-Remote-Audit-Analysis-May-2021
JAMS report available
On the CAMD website: https://www.camd-europe.eu/regulatory/the-jams-laymans-report-is-now-available-online/
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