Eisner Safety Consultants

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.

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 [...]

A new LinkedIn group has been formed thx to the support of the IEC (International Electrotechnical Commission)*.  The group name is the IEC 60601 series of standards on Medical Electrical Equipment.  This group is not just about the 3rd edition of IEC 60601-1 but about the whole series of IEC 60601 series of standards and [...]

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 [...]

On 10 Oct 2012 The European Association for Medical devices of Notified Bodies (better known as Team-NB) issued a press release on the adoption of Version 3.0 of the Code of Conduct (CoC) for Notified Bodies under Directives 90/385/EEC (Active Implantable Medical Devices Directive), 93/42/EEC (Medical Devices Directive), and 98/79/EC (In-Vitro Diagnostic Directive) that is [...]