Eisner Safety Consultants

The new MHRA website home page is now live and you are being sent to the Home Page of the newly revamped site! The UK MHRA has updated their website to be much more functional and you can find a lot of information about the Directives (i.e. MDD, IVD, & AIMDD) related to the medical [...]

COCIR, the European industry association representing the radiological, electromedical and IT industries, issued (on 22 Nov 2010) a decision diagram to determine if software is considered a medical device per the Medical Device Directive (MDD) 93/42/EEC including the amendment.  The document includes a clear definition of what software includes, which is a wide range of [...]

This article is courtesy from BSI Healthcare eUpdate of 11-APR-2011.  We send out thanks to BSI for such an informative and critical article for the medical device and IVD industries selling product in Europe (EU). Medical device manufacturers should be aware that it is not only the medical devices directives that are currently being considered [...]

On 16 November 2010 this Interpretative Document was issued to explain what is considered Placing Medical Devices on the EU Market.  The document refers to all 3 medical device directives including the amendment 2007/47/EC.  The 3 medical device directives this applies to are Active Implantables Medical Devices 90/385/EEC, Medical Devices 93/42/EEC, and the InVitro Diagnostic [...]

Eisner Safety Consultants Newsletter #6 – published 6/30/2010 & covers Recent news on IEC/EN 60601-1:2005/2006; Classification MedDev, Clinical Data & Usability Analysis Requirements per the Amended MDD; and Rechargeable Batteries with Inductive Coupling Download all our newsletters at http://www.EisnerSafety.com/esc-news/