1 Step Closer to EU Medical Device e-Labeling

leoeisner — Tue, 17 Jan 2012 19:38:05 +0000

Per Eucomed’s 7 October 2011 newsletter electronic labeling of medical devices (MDD & AIMDD) has been approved as a draft regulation and is in the hands of “the Council and European Parliament who will have 3 months to exercise their right of scrutiny and evaluate whether the European Commission has exceeded its powers with this proposed regulation.

Final publication and entry into force is expected at the beginning of 2012.”

EC publishes draft regulation on electronic IFUs of Medical Devices

leoeisner — Fri, 24 Jun 2011 18:40:06 +0000

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 2011 to analyse this latest version of the proposal, which was previously extensively discussed with the European Commission during its initial development.

For more information on the Eucomed Alternative Labeling Task Force or if you have any questions, please contact Dario Pirovano (Dario.pirovano@eucomed.org).‘

Draft regulation on Electronic IFU for medical devices.

Electronic IFU – Eisner Safety Consultants

1 Step Closer to EU Medical Device e-Labeling

EC publishes draft regulation on electronic IFUs of Medical Devices