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May 2018

Team-NB sector survey is available on our website

Team-NB sector survey is available on our website

Team-NB sector survey in 2017

April 2018

During an information meeting on the new European regulation on medical devices organized by the French competent authority – ANSM, the management reports on the survey carried out by Team-NB

During an information meeting on the new European regulation on medical devices organized by the French competent authority – ANSM, the management reports on the survey carried out by Team-NB

http://ansm.sante.fr/var/ansm_site/storage/original/application/72e6f37068b331cafe83c6782fc90bb8.pdf

March 2018

Team-NB participates at the roundtable on standard and guidelines for safety mechanisms in the Medical Devices Regulation and Sharps Directive to improve healthcare worker, patient and user safety under the aegis of Rory Palmer, MEP.

Team-NB participates at the roundtable on standard and guidelines for safety mechanisms in the Medical Devices Regulation and Sharps Directive to improve healthcare worker, patient and user safety under the aegis of Rory Palmer, MEP.

Team-NB participated at the Advisory board meeting, Joint Action on market surveillance of medical devices

Team-NB participated at the Advisory board meeting, Joint Action on market surveillance of medical devices

Team-NB represented at the 1st MDCG meeting open to stakeholders

Team-NB represented at the 1st MDCG meeting open to stakeholders

February 2018

Survey on applications by the Team-NB member notified bodies under the MDR/IVDR and how this compares with their current scope under the three current directives AIMDD/MDD/IVDD.

Survey on applications by the Team-NB member notified bodies under the MDR/IVDR and how this compares with their current scope under the three current directives AIMDD/MDD/IVDD.

Team-NB-Press-Release-Applications-Survey-20180214

Team-NB participates at the international workshop on global use and application UDI.

Team-NB participates at the international workshop on global use and application UDI.

January 2018

MedTech forum : Team-NB members answered the questions of the audience in the session: “What’s happening with Notified Bodies?”.

MedTech forum : Team-NB members answered the questions of the audience in the session: “What’s happening with Notified Bodies?”.

The CAMD (Competent Authorities for Medical Devices) published on their web site 2 documents related to FAQs to the transitional provisions of MDR and IVDR.

The CAMD (Competent Authorities for Medical Devices) published on their web site 2 documents related to FAQs to the transitional provisions of MDR and IVDR.

http://www.camd-europe.eu/media-centre

November 2017

Article in Politico by Sarah Wheaton

Article in Politico by Sarah Wheaton

GAMETIME FOR NOTIFIED BODIES: This Sunday, the starting gun fires [...]