Eisner Safety Consultants

This Regulation Chart & the blog post contents is Thx to Medicaldeviceslegal.com and the RAPS Dutch/Flanders chapter.  We are grateful to them for sharing such a valuable tool and hope you get a lot of good use from it too.  All they ask you do is to provide them with feedback if you have ideas of additional [...]

The  International Medical Device Regulators Forum (IMDRF) has been really busy of late, which is a good thing as many in the medical device industry are still wondering if the IMDRF will live up to the “Big Shoes” that the GHTF left behind when it was decommissioned in the last. In another post I will [...]

On 7 March 2013 the EU released the Regulation on the electronic publication of the Official Journal of the European Union.  This regulation states that “The Official Journal shall be published in electronic form”, which unofficially it has been accessible for quite a long time, “in the official languages of the…European Union.”  Currently there are [...]

This post is based on the Impact of the Draft report on the EU MDD proposed regulations and comes from posts, opinion pieces and stories from MedTech Europe, Eucomed & Erik Vollebregt (medicaldeviceslegal.com) If you are reading this post my guess is you already know the proposed MDD regulations are contentious and that there is some [...]

This blog post is thx to our associate Christine Ruther and a special thx goes out to Helene Spencer. MEDDEV 2.12-1 Guidelines on a Medical Devices Vigilance System was updated in January 2013.  The revised guidance is applicable as of July 2013.   The revision contains clarifications rather than significant changes.