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The European Commission has just issued guidance on the vigilance system for medical devices under the EU medical devices directive
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 adverse...
European Commission launches new information on Unique Identification System
[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...
La Comisión Europea lanza nueva información sobre el sistema de identificación única
[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...