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 asks for further scientific study & draws 1st lessons from recent fraud on breast implants
From the Europa website the following press release was issued on 2 Feb 2012. The complete press release is below. The original press release may be viewed too. European Commission – Press release Medical devices: European Commission asks for further
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
EU AUS Med Dvc MRA but Mfr’s Be Careful
This Mutual Recognition Agreement on standards and conformity assessment between Australia and the European Community has been in effect since 1 Jan 1999. But the list of Conformity Assessment Bodies (CAB) for the EU doesn’t cover every EU Medical Device