AESGP Conference
Team-NB was invited as speaker at the Amsterdam event.
The Corrigendum has been published.
Possibilities for Members States to send comments until Wednesday March 20th end of day. For MDR, the part in English is at page 38. For the MDR : https://data.consilium.europa.eu/doc/document/ST-15409-2018-REV-1/en/pdf To be noticed some significant changes In Annex VII regarding the fact “ that the entire range of devices covered by the certificate is sampled” In Annex IX [...]
Team-NB published a press release regarding the capacities of notified bodies to meet the sector needs.
Team-NB-Press-Release-Survey-Capacities-February-20190228
Team-NB publishes a press release regarding the designation process in the framework of the IVDR regulation.
Team-NB-Press-Release-IVDR-Applications-Survey-20190117
Team-NB is publishing a survey on the MDR designation process present stages in which Team-NB notified bodies member are.
Team-NB-Press-Release-Applications-Survey-20181218
NB-Med and Team-NB have jointly edited a white paper entitled “White Paper – One Year of Application”
White Paper - One Year of Application