Commission Implementing Regulation (EU) 2020/666 of 18 May 2020 amending Implementing Regulation (EU) No 920/2013 as regards the renewal of designations and the surveillance and…
Posts published in “In Vitro Diagnostic Medical Devices Directive – IVDMDD”
Manufacturer incident report 2020 Manufacturer incident report for importing XML file with Adobe Professional 2020 Changelog file 2020
Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions
Joint Action on Market Surveillance of Medical Devices (JAMS) Stakeholder Conference Held In Brussels On Dec. 12th 2019
The Commission concluded that it will only be possible to make EUDAMED operational once the entire system and its different modules have achieved full functionality…
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…