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
Eisner Safety Consultants Newsletter #6 Now Online
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/
Updated EN60601 Series FAQ Posted on Cenelec site in regard to the MDD & AIMD & EN60601 Series
Updated EN60601 Series FAQ Posted on Cenelec site in regard to the MDD & AIMD & EN60601 Series The current document posted on 22 March 2010 is an update to the previously posted document issued 9 October 2009 on the CENELEC
Updated EN60601 Series FAQ to be Posted on Cenelec site soon
Updated EN60601 Series FAQ in regard to the MDD & AIMDDD to be posted on CENELEC website in the near future The document is an update to the current posted document issued 9 October 2009 on the CENELEC site
TÜV SÜD Info Newsletter on MDD declarations of conformity required – yes or no?
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