Newsletter Summary

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 on March 21, 2010.  There is no transition period for the amendment to the MDD.

First, we are presenting an audio conference titled “Is Your Product Development Cycle Ready for IEC 60601-1 3rd Edition?” which will be on March 25^th.  Please come and join in the audio conference.  See below for a special discount code that only Eisner Safety Consultants is able to provide to you.  Next we want to remind you about the MDD Amendment deadline and that we can help you out with our MDD Amendment Toolkit, which is only $249.00.  Our third article summarizes the recent important information related to 60601-1, 3^rd ed. and related standards.  This is a must read especially the part with the FDA.  Lastly, we let you know that there are 3 different ways to get up to date notices from Eisner Safety Consultants (ESC Updates) on the medical device industry regulatory, product safety and quality system news.

If you have any questions regarding any of the subjects of this newsletter please feel free to contact us.  We hope you enjoy our fourth newsletter and we would enjoy hearing back from you on any suggested topics and your feedback.

• Newsletter Summary
• IEC 60601-1, 3rd ed. Audio Conf. $50 Off
• MDD Amendment Less than 1 week til Mandatory
• Important 60601-1 News
• 3 Ways How to get your ESC Regulatory & Compliance Updates

Recent Regulatory Implications for IEC 60601-1, 3^rd ed.
Join Us for a 1 Hour Audio Conference on March 25 2PM EST
for Only $199

Within the last couple weeks there have been some big changes that will impact how and when your company decides to transition to the 3^rd edition of IEC 60601-1, if you haven’t already.  To find out more join us for an FX Conferences hosted event titled “Is Your Product Development Cycle Ready for IEC 60601-1 3rd Edition?”  The material will be presented by Leo Eisner of Eisner Safety Consultants.  The audio conference is Thursday March 25, 2010 starting at 2PM Eastern.

To get a $50 discount for this event use the special promotion code AF2009EIS when you sign up at the FX conferences website. Continue reading more information on this audio conference.

Note, that if you can’t join us live for the event you still can sign up to receive the recording after the event.

Less Than 1 Week Before The MDD Amendment Changes Are Mandatory!Is Your Company In Full Compliance With The Amendment 2007/47/EC?

If your company isn’t quite ready by Saturday March 20, 2010 you may have to stop selling & distributing product into the EU on March 21,2010. We have the solution to help you get thru the transition with our MDD Amendment Toolkit to help meet the MDD Amendment 2007/47/EC – It is only $249.00. The changes to the current EC Medical Device Directive (MDD) 93/42/EEC become mandatory on March 21, 2010. All manufacturers of CE marked medical devices must be in compliance by that date. There is no transition date for the amendment 2007/47/EC. Eisner Safety Consultants in conjunction with Roberts Consulting & Engineering is offering a package for device manufacturers to assist them in complying with the changes. Click here to order the package.

The package contains useful resources to make your job easier in meeting the new changes in a timely and efficient manner. We e-mail the package to you typically within a few hours.

This exciting new package is available on the Eisner Safety Consultants website for $249.00. You can order with a credit card or a Paypal account.

Important 60601-1 News Updates

There have been some big news items of late for IEC 60601-1 and all have been posted on our Industry News page and been Tweeted too. (See below article to see ways to stay up to date on these issues)

• FDA is posed to formally recognize the 3^rd ed of IEC 60601-1 hopefully in June and they would set-up a 3 year transition period. Many medical device manufactures have been awaiting this news for several years now.
• Updated EN60601 Series FAQ to be Posted on Cenelec site soon
• Amendment 1 of IEC 60601-1:2005 is at the 1^st committee draft stage (1CD) and the estimated publication date is June 2012.
• AAMI has released Amendment C1 for ANSI/AAMI ES60601-1:2005 which is identical to Corrigendum (Errata Sheets) 1 & 2 of IEC 60601-1:2005.
• ANSI/AAMI/IEC TIR62354:2009 – General testing procedures for medical electrical equipment – This is a great resource to understand how the tests in IEC 60601-1:2005 are to be conducted. Note that the IEC version is published already

How Would You Like to Get Your Regulatory & Compliance Updates?
Options Abound via Blog, RSS Feed, & Twitter too

You can access this information in the way that works best for you:

• thru our Industry News page (our Blog) at www.EisnerSafety.com/industry_news/
• by subscribing to our RSS feed  on the Industry News page
• and our newest feature is to join us at