Here is the summary of decisions taken : • the UDI/Device module will be released in Production in September 2021. Voluntary use is possible and workable. • the NBs and Certificates module will be released in Production in September 2021 with the exception of the CECP and the Mechanism for scrutiny, which will remain in [...]
The aims are to help the auditors to assess in a remote way againt MDR and to harmonise practices. It appears that the practices are already reasonably harmonised; only minor differences. A second training is already planned end of August.
All the information and contact are available on https://app.gignow.com/ey/job_postings/6a654c78d8bb442897d756e9d832b215.
Team-NB representative operates a session on the implementation of the new IVD regulation organised by SIDIV for its members
Team-NB has been invited to speak at this webinar (agenda attached)Agenda for webinar on sharps injuries and the MDR 08.06.21
A very significant survey thanks to the answers of 46 NBs (on 52 designated).CIRCABC-Remote-Audit-Analysis-May-2021
On the CAMD website: https://www.camd-europe.eu/regulatory/the-jams-laymans-report-is-now-available-online/
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.