Team-NB published a press release regarding the survey run among its members to analyse the certificates being issued.
Team-NB-MD-Sector-Survey-PressRelease-20190524
Team-NB-MD-Sector-Survey-PressRelease-20190524
Team-NB was invited as speaker at the Amsterdam event.
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-Press-Release-Survey-Capacities-February-20190228
Team-NB-Press-Release-IVDR-Applications-Survey-20190117