The following is provided thx to one of Eisner Safety Consultants Associates, Christine Ruther, and many thanks to NSAI the Irish Notified Body: The European Competent Authorities have formed a Central Management Committee (CMC) to achieve greater consistency in the
Electronic IFUs for EU MDD & AIMDD Devices
The following is provided thx to one of Eisner Safety Consultants Associates, Christine Ruther: The Commission Regulation of electronic instructions for use (IFUs) of Medical Devices 207/2012 was released 10 March 2012. Here’s a general summary: The directive does not cover
EC publishes draft regulation on electronic IFUs of Medical Devices
24 June 2011 – From Eucomed e-newsletter – European Commission publishes draft regulation on electronic instructions for use (IFU) of medical devices. ‘Stakeholders can send their comments by 8 August 2011. The Eucomed Alternative Labeling Task Force will meet on 1 July