por Isabel | Jul 19, 2019 | Blog EN
The launch of the surveillance system guidance is linked to a new version of the manufacturer’s incident report (MIR) that will become mandatory in 2020. This new version introduces the use of the International Medical Device Regulators Forum (IMDRF) consensus...
por Isabel | May 22, 2019 | Blog EN
[vc_row][vc_column][vc_column_text]On 3 May, the European Commission launched three consultation documents for medical device manufacturers, which include important information on the UDI (Unique Device Identifier) system for medical devices. Two of them include...
por Isabel | May 22, 2019 | Regulación
[vc_row][vc_column][vc_column_text]El pasado 3 de mayo la Comisión Europea lanzó tres documentos de consulta para los fabricantes de productos sanitarios, que incluyen información importante sobre el sistema de identificación única para productos sanitarios UDI...