Category: In Vitro Diagnostic Medical Devices Directive
April 2019 update of the MDR and IVDR implementing measures rolling plan
Processo de designação para o IVDR – Regulation (EU) 2017/746 dos membros do Team-NB http://www.team-nb.org/team-nb-publishes-a-press-release-regarding-the-designation-process-in-the-framework-of-the-ivdr-regulation/
Manufacturers with CE Marking shall update their procedures and forms. Fabricantes com Marcação CE devem atualizar seus procedimentos e formulários. Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (MDD/IMDD/IVDD) New Manufacturer Incident Report helptext.