Eisner Safety Consultants

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.

18 April 2013 – The NB-MED EN62304:2006 issues team released their first official version (V1.0) dated 5 April 2013 of this importnat implementation document in regards to EN 62304 with respect to the Medical Device Directive 93/42/EEC on the NB-MED website.  EN 62304 is the standard for MEDICAL DEVICE software – Software life-cycle processes. The document is [...]

The EN 980 Symbols for use in the labeling of medical devices standard was mistakenly taken off of the EU Harmonized List of standards on the Jan 24, ’13 release and EN ISO 15223-1 Medical devices — Symbols to be used with medical device labels, labeling and information to be supplied — Part 1: General [...]

As of November 2012 the GHTF (Global Harmonization Task Force) is no longer operating as evidenced by several pieces of information.  In it’s place the International Medical Device Regulators Forum (IMDRF) is working to “build on the strong foundation of the GHTF’s” 20 years and the aim is to “accelerate international medical device regulatory harmonization [...]