On March 3rd join FX Conferences and Leo Eisner to learn about the home healthcare environment and the proposed emergency medical services standards, respectively IEC 60601-1-11 & IEC 60601-1-12 (hopefully).  More information can be found on our blog post on this topic.

On March 4th  join Leo Eisner in Foster City, CA as he & several other presenters focus on the topic of “Evolving Risk-Based Regulatory Requirements” for a whole day workshop put on by RAPS (SF Bay Area Chapter) & ASQ (Biomedical Division Northern CA Discussion Group).  Leo will be presenting on the 3rd ed. of IEC 60601-1, the series of standards, and also the impact of change on the medical device industry.  Other topics will include Usability & Human Factors verification, validation, and regulatory requirements; and Clinical evaluation & investigation regulatory requirements. More information can be found on our blog post on this topic.

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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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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

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.