Eisner Safety Consultants

From the Europa website the following press release was issued on 2 Feb 2012. The complete press release is below.  The original press release may be viewed too. European Commission – Press release Medical devices: European Commission asks for further scientific study and draws first lessons from the recent fraud on breast implants Brussels, 2 [...]

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/

Eisner Safety Consultants Newsletter #5 Now Online This issue we are going to focus on primarily on IEC/EN 60601-1:2005/2006 as there is some significant news within the last few weeks and more to come really soon.  Also, we would be remiss if we didn’t remind you that the MDD Amendment 2007/47/EC becomes mandatory this weekend [...]

In the April 2009 edition of our medical information flyer ‘Transition to EC Directive 2007/47/EC’, we informed you that we assumed, in view of the status of discussions at that time, that new declarations of conformity would have to be issued. In our newsletter of 2 July 2009 we revised this statement and explained that [...]