Eisner Safety Consultants - ESC News Issue #6



Eisner Safety Newsletter Issue 6 — June 30, 2010
IN THIS ISSUE	Newsletter Summary This issue is packed full of important updates and useful information. First, we are going to focus on additional updates with regard to IEC/EN 60601-1:2005/2006 as there is significant news since the last issue of the ESC newsletter. Next we delve into the MDD Amendment 2007/47/EC specifically on the updated Classification MEDDEV and the new Clinical Data requirements. We also would like to remind you when your EU MDD Notified Body is up to reviewing your technical file or design dossier you need to make sure you have addressed the Usability and Clinical Data requirements as they apply to all medical devices under the MDD Amendment. If you need help with these new requirements to the MDD we have a toolkit that will be helpful to you. Lastly, our Associate Christine Ruther writes about an FCC publication in regard to medical devices that use inductive coupling to recharge batteries. If you have any questions regarding any of the subjects of this newsletter please feel free to contact us. We hope you enjoy our sixth newsletter and we would enjoy hearing back from you on any suggested topics and your feedback. Thx, Leo Eisner - Newsletter Editor & Writer
NEWS
Newsletter Summary IEC 60601-1, 3rd ed. Big News MDD Classification MedDev 2.4.1 Updated Clinical Data Rqrts Are You Ready for Usability Analysis or Clinical Data? Recharge Batteries with Inductive Coupling

INDUSTRY NEWS on EisnerSafety.com NAMSA offering seminars – Biocompatibility of Med. Dvcs Aug – Oct, ‘1 FDA Formally Recognized AAMI ES60601-1:2005 as Consensus Std 6/10/10 Joint FDA/FCC public mtg 7/26-27 – Enabling Convergence of Communication & Medical Systems Major Regulatory Decisions on IEC60601-1, 3rd ed. (UL White Paper) Firms (i.e. Dell, HP, Sony, etc.) Urge EU Restrict Add’l Substances (BFRs & PVCs) in RoHS by 2015 Forward to an associate if you think they would benefit from it.
	IEC 60601-1, 3^rd ed. Big 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 at EisnerSafety on Twitter FDA has formally recognized the US National Version of 3rd ed of IEC 60601-1 (AAMI ES 60601-1:2005) on June 10, 2010. At the end of the three-year transition period of June 30, 2013 IEC 60601-1:1988 (2^nd ed.) will not be accepted for any FDA submission (i.e. 510(k), IDE, PMA, etc.) anymore. Updated EN60601 Series FAQ has been Posted on Cenelec site. It explains how EN 60601 series of standards, 2^nd & 3^rd ed., works in relation to the requirements of the EU MDD and AIMDD. Underwriters Laboratories (UL) has issued a white paper on the Regulatory Decisions in relation to IEC 60601-1, 3^rd edition. 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. If you need help with the transition to 3^rd edition of IEC 60601 series or of any of the national standards we can offer you the level of service that fits your needs. Contact us at Leo@EisnerSafety.com to discuss your needs.

	MDD Classification MedDev 2.4.1 updated to include 2007/47/EC amended requirements This revised document provides guidance for the application of the classification rules under Annex IX, Classification Criteria, of the MDD (93/42/EEC) as amended by 2007/47/EC. MedDev 2.4.1 revision 9 was formally released June 2010. To obtain this updated document and to find other Medical Device Directive Guidance Documents (MEDDEV’s) come to our Resource Library.

	TÜV SÜD Information Bulletin on Updated Clinical Data Requirements The Notified Body TÜV SÜD has issued an Information Bulletin regarding the more extensive requirements for Clinical Data for Medical Device Technical Files under 2007/47/EC amendment to MDD 93/42/EEC. All classes of devices need to meet the Clinical Data requirements detailed in the Amended MDD. This Information Bulletin is useful in summarizing the requirements.

	Are You Prepared When Your Notified Body Requests a Usability Analysis or Clinical Data Based on the MDD Amendment 2007/47/EC? If your company has not had their Notified Body review your MDD Technical File or Design Dossier to the Amended MDD 2007/47/EC you may get a surprise that you need to have a Usability Analysis or Clinical Data for all classes of devices, as these are requirements of the Amended MDD per 2007/47/EC. We are selling the MDD Amendment Toolkit to help meet these MDD Amendment 2007/47/EC requirements – It is only $249.00. The changes to the current EC Medical Device Directive (MDD) 93/42/EEC became mandatory on March 21, 2010. There is no transition date for the amendment 2007/47/EC. So, the next time your Technical File or Design Dossier is up for review by your Notified Body, you will be prepared with this information if you purchase this Toolkit. 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.

	Does Your Medical Device Use Inductive Coupling to Recharge Batteries? FCC Publication 680106 is here This article is written by our associate Christine Ruther Many medical devices, especially implants, are using inductive coupling to recharge batteries. The FCC now requires that manufacturers consult with the FCC for inductive charging systems per publication 680106. You can find the document by visiting http://www.fcc.gov/labhelp and searching for publication number 680106 or http://ht.ly/1VWoo (this gets you straight the pub # 680106). The information on what to send and where to send it is in the publication. Note that you should request confidentiality on submitted attachments when sending information to the FCC (there is an obvious checkbox to tick) so that they can prevent the information from being released under Freedom Of Information rules. If you have questions or need help with this or a related issue, please contact us at newsletter@EisnerSafety.com
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MD&DI article on IEC 60601-1 3rd edition