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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 our 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 Amendments. 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.

We hope you enjoy this edition of the newsletter and we would enjoy hearing back from you on any suggested topics and your feedback.

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There is additional information, including how collateral and particular standards will be treated and how US National infrastructure requirements enacted as statue (e.g. NFPA 99) will be implemented with this Standard, and how Risk Management will be used with this standard, on the FDA Consensus Standard web page for ANSI/AAMI Es 60601-1:2005 http://ht.ly/22kSQ

The current document posted on 22 March 2010 is an update to the previously posted document issued 9 October 2009 on the CENELEC site

The newest document has added in a few critical issues including

• that with the publication of EN 60601-1:2006, compliance with EN 60601-1:1990 and its related collateral standards will no longer give ‘presumption of conformity’ with the European directives covered as of 1 June 2012.  This date 2012 was confirmed by the CENELEC Technical Board in October 2009 (decision D135/C228). Publication in the Official Journal of the European Union is necessary for this decision to enter into force. The publication of the 1 June 2012 date is expected in spring 2010.
• devices should not be presumed to be unsafe simply because they were designed to comply with EN 60601-1:1990 when first introduced into the European market. Whether or not the safety of such devices represents the “state of the art” can only be determined through the application of Risk Management according to EN ISO 14971 and especially with regard to Clause 9 thereof.
• For those medical devices for which a part 2 exists (i.e., a standard labeled EN 60601-2-x or EN 80601-2-x), the transition period for that part 2 is decisive.  If the transition period of the part 2 ends, for example, on 21 November 2011 then, after this date, compliance with the old (‘superseded’) standard no longer gives the presumption of conformity with the Essential Requirements covered by the standard. In this situation, the 1 June 2012 date is not relevant.
• and more CENELEC site link

From  FDA News Devices & Diagnostic Letter March 29, 2010

Devicemakers may have to pay up to 40 percent more to test the safety and effectiveness of electronic devices now that CDRH has adopted an international standard for electronic devices.

Manufacturers will have three years to comply with the third edition of the International Electrotechnical Commission’s (IEC) 60601-1, Carol Herman, director of standards management at CDRH, said at a recent Association for the Advancement of Medical Instrumentation (AAMI) conference. The agency hopes to publish a notice of the change in the Federal Register by June, she added.

Many Changes

The complex standard sets general requirements for basic safety and essential performance of medical electrical equipment. Unlike most revisions, which average three to five major changes, the third edition of the IEC standard includes 114 subclauses not listed in the second edition, introduced in 1988, John Drengenberg, consumer affairs manager at Underwriters Laboratories, told D&DL.

The new standard allows devicemakers to employ less stringent requirements for operator safety, mechanical safety factors and surface temperatures, Frank O’Brien, president of O’Brien Compliance Management, told D&DL. But for electronic devices on wheels, the standard includes more stringent requirements for stability and rough handling.

The standard also allows devicemakers to use components, such as power supply units, designed for the IT industry, which could offset other costs, Mike Schmidt, co-chairman of AAMI’s electrical safety committee, told D&DL.

To help devicemakers transition to the new standard, CDRH plans to release two guidances. The first, which should come out sometime this year, would cover general principles of how to use the standard based on the FDA’s perspective of safety and effectiveness, Leo Eisner, a safety consultant who has worked with FDA officials, told D&DL.

The second guidance, which will not be issued until the FDA determines what changes to make to its 510(k) and PMA processes, will advise manufacturers on what information will be required in marketing applications for electronic devices, he said.

Harmonizing Standards

CDRH’s adoption of the IEC standard was inevitable given the FDA’s push to harmonize its regulations, Steve Strong, vice president of quality assurance and regulatory affairs at Minnetronix, told D&DL. Minnetronix specializes in the design and manufacture of electronics-based devices.

With Canada, Europe and the U.S. in various stages of implementing the IEC standard, 75 percent of device regulators should be in alignment with the provision by 2013, O’Brien said.

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 fifth newsletter and we would enjoy hearing back from you on any suggested topics and your feedback.

To see past editions of the newsletter go to www.EisnerSafety.com/esc-news/. Subscribe to the newsletter to get future newsletters.  Go to any page on the website and enter your e-mail address in the upper left side of the webpage where it says “Sign-Up to our Newsletter”.

The document is an update to the current posted document issued 9 October 2009 on the CENELEC site

The newest document will add in a few critical issues including

• that with the publication of EN 60601-1:2006, compliance with EN 60601-1:1990 and its related collateral standards will no longer give ‘presumption of conformity’ with the European directives covered as of 1 June 2012.  This date 2012 was confirmed by the CENELEC Technical Board in October 2009 (decision D135/C228). Publication in the Official Journal of the European Union is necessary for this decision to enter into force. The publication of the 1 June 2012 date is expected in spring 2010.
• devices should not be presumed to be unsafe simply because they were designed to comply with EN 60601-1:1990 when first introduced into the European market. Whether or not the safety of such devices represents the “state of the art” can only be determined through the application of Risk Management according to EN ISO 14971 and especially with regard to Clause 9 thereof.
• For those medical devices for which a part 2 exists (i.e., a standard labeled EN 60601-2-x or EN 80601-2-x), the transition period for that part 2 is decisive.  If the transition period of the part 2 ends, for example, on 21 November 2011 then, after this date, compliance with the old (‘superseded’) standard no longer gives the presumption of conformity with the Essential Requirements covered by the standard. In this situation, the 1 June 2012 date is not relevant.
• and more to be seen when issued on the CENELEC website.  I will post the link to the new FAQ when it is published.

From AAMI March 12, 2010 press release

The U.S. Food and Drug Administration (FDA) will formally recognize the electrical equipment standard IEC 60601-1/Ed.3:2006.

Carol Herman, director of standards at the FDA’s Center for Devices and Radiological Health (CDRH), made the announcement during the Association for the Advancement of Medical Instrumentation (AAMI)/FDA International Conference on Medical Device Standards and Regulation, which took place in Reston, VA, March 9-10.

“We will not only recognize the third edition of the standard, but we will also recognize all collaterals and all particulars,” Herman told attendees.

The third edition of 60601-1 offers general requirements for basic safety and essential performance of medical electrical equipment. It also contains requirements for reliable operation to ensure safety.

CDRH hopes to publish notice of the recognition in the Federal Register by June, Herman said. Once the notice is published, users will have three years to transition to the third edition and the related collaterals and particulars, Herman added.

The standard already has been recognized and harmonized in Europe for the last several years, said Charles Sidebottom, director of corporate standards for Medtronic and secretary of IEC/Sub Committee 62A, which developed the standard.

Sidebottom, who is chair of AAMI’s Board of Directors, says that the subcommittee has been working with CDRH staff to get the standard recognized since well before it was even published. “For us that is a real big deal that the agency formally announced recognition of the whole collection of standards,” he said.

AAMI had adopted its own version of the standard with national deviations called ANSI/AAMI ES60601-1:2005 (IEC 60601-1:2005, MOD), which includes original IEC text where U.S. modifications are introduced for easy comparison of requirements, as well as a number of the collateral and particular standards.

Changes on the Horizon

The CDRH recognition comes as a new amendment to 60601-1 is under development, which includes some changes to the original standard.

One of the proposed changes focuses on extending the scope of 60601-1 to include medical software systems. The amendment includes a definition of medical software systems and associated technical requirements.

The amendment also aims to streamline the application of risk management. It clarifies how a manufacturer should apply the standard’s requirements when evaluating residual risk, Sidebottom said during a presentation at the conference. When there are specific requirements with specific acceptance criteria, compliance is “presumed to establish acceptable risk,” Sidebottom added. The amendment also revises how to establish alternative risk controls or test methods.

The amendment clarifies the definition of essential performance to more fully explain the process for identifying essential performance and mitigating the risks associated with its loss or degradation, said Sidebottom. “Essential performance is performance other than that related to basic safety,” he said. “In many cases, differentiating between basic safety and essential performance is not that important because the standard says both have to be maintained. However, in some cases it is important to draw that distinction so the standard needs to be clearer about how the manufacturer should go about identifying the essential performance.”

The amendment is expected to be published in August 2013.

Yes, it is true these old standards finally have been withdrawn.  UL’s announcement on December 21, 2009 stated “UL announces the withdrawal of the seventh edition of the Standard for X-Ray Equipment, UL 187, and the fourth edition of the Standard for Medical and Dental Equipment, UL 544, and their replacement with the first edition of the Standard for Medical Electrical Equipment, Part 1: General Requirements for Safety, UL 60601-1.”

This issue we are going to focus on the 60601-1 series of standards based on the 3^rd edition of 60601-1 and the MDD & AIMDD, including the Amendment 2007/47/EC for the MDD.  First we are presenting an audio conference on the Marking and Labeling requirements for IEC 60601-1 which will be on November 18^th.  Please come and join in the audio conference.  Next we summarize the issues discussed on the CENELEC FAQ web page dealing with EN 60601-1, 3^rdedition questions that apply to the MDD and AIMDD.  Then we discuss the big changes coming down the line for the draft EMC Standards IEC 60601-1-2, 4^th edition & the new IEC 6XXXX, 1^stedition.  This is a must read article for any electrical medical device manufacturer.  Lastly, we remind you that there are less than 5 months left til the MDD Amendment requirements come into play.  One way to deal with this is to use our MDD Amendment Toolkit, which is only $249.00.

We hope you enjoy the third edition of our newsletter and we would enjoy hearing back from you on any suggested topics and your feedback.

To see past editions of the newsletter go to www.EisnerSafety.com/esc-news/. Subscribe to the newsletter to get future newsletters.  Go to any page on the website and enter your e-mail address in the upper left side of the webpage where it says “Sign-Up to our Newsletter”.

Audio Conference is on Wednesday Nov. 18, 2009, 1:00pm – 2:00pm Eastern Time, 60 minutes

Get a $50 discount ($199 after discount) for this event by using the special promotion code AF2009EIS when you sign up at the FX conferences website

Audio conference highlights

Get up to speed on the latest requirements incorporated into the 3rd Edition of IEC 60601-1 and take the guesswork out of marking and labeling your medical devices! Marking and labeling is just one area to tackle in the complicated development of medical devices, but it is a critical one to understand. How do you make sense of all those regulations? It’s challenging enough preparing and testing the device; then you have to worry about the user manuals, screen prompts and packaging too.

In this audio conference, Leo Eisner guides you through each new, added or modified regulation incorporated into the most recent revision of IEC 60601-1. The third edition of this cornerstone standard for medical electrical devices sees major changes from the second edition, changes you need to know about for successful compliance. Ease your marking and labeling stress with detailed guidance from a leading expert.

This audio conference covers:

• How risk management relates to labeling and marking
• New testing requirements under IEC 60601-1 3rd edition
• The important document you need for “proof of compliance”

Who should attend?

• Product safety engineers
• Regulatory affairs
• Technical writers
• R&D engineers

Sign-up for the audio conference right here and use promo code AF2009EIS for a $50 discount on this event only

CENELEC has issued a FAQs page on their website to clarify many of the confusing issues surrounding the EN60601 series of standards including the general (or base standard EN60601-1), the collateral standards (e.g. EN60601-1-XX), and the particular standards (e.g. EN60601-2-XX).  The FAQs page includes clarification on transition dates for these standards.  To go to the CENELEC website FAQs page click here.

This newsletter contains articles on IEC 60601-1, 3rd ed (published in MD&DI – Sept ‘09), The Amendment to the Medical Device Directive, Pre-Announcement of our Gap Analysis & Update Package for the MDD Amendment 2007/47/EC, our Standards & Regulations Update Service, announcement of the Medical Device Track at the Oct ‘09 IEEE Product Safety Engineering Society, and on the launch of Eisner Safety Consultants New Website.

Subscribe to the newsletter to get future newsletters.  Go to any page on the website www.EisnerSafety.com and enter your e-mail address in the upper left side of the webpage where it says “Sign-Up to our Newsletter”.

The article discusses when IEC 60601-1:2005 will be mandatory, including the US, EU, & Canadian National versions.  There is a look at the development of the standard and why implementation has taken so long.  As there can be conflicting requirements for the manufacturers the article discusses the steps to consider in developing a company strategy to transition from second to third edition for its product lines. This last item is a special segment in the web version only.