In our newsletter of 2 July 2009 we revised this statement and explained that not all declarations of conformity might have to be re-issued in general.

Subsequent discussions with several authorities and Notified Bodies revealed that the issue of new declarations of conformity has not yet been discussed clearly and uniformly across all EU Member States and that therefore the statements of the individual Member States on this subject also differ. While some EU Member States consider the issue of new declarations of conformity as unavoidable in general, other EU Member States consider internal evidence of compliance to be sufficient.However, not only the European authorities, but other stakeholders too are interested in a declaration of conformity; they include hospital purchasing departments, registered practitioners and non-EU authorities.
Given this, we expect further discussions between authorities, manufacturers and Notified Bodies on the issue of new declarations of conformity. The cases in which no new declaration of conformity has been issued, may require increasing coordination and agreement between manufacturers and clients and/or authorities and/or suppliers or sub-contractors in the future.

In view of the fact that by 21 March 2010 many harmonized standards will lose their status as evidence of compliance with the essential requirements, we can only advise manufacturers at present to consider whether it may not be more sensible to issue a new declaration of conformity in order to keep all further discussions, phone conversations and correspondence to a minimum.

All declarations of conformity which are issued before 21 March 2010 and which are to document evidence of compliance with 2007/47/EC must include reference to 2007/47/EC. Such reference may be omitted in declarations of conformity issued after 21 March 2010, as Directive 2007/47/EC applies as a matter of principle and other options are no longer available.

Compliance with the essential requirements of the medical devices directive no longer ensured

Harmonized standards are published in the Official Journal of the European Union. Medical devices complying with the requirements of the standards listed in these publications may be assumed to comply with the essential requirements of the Medical Devices Directive.

Through this newsletter, we would like to draw your attention to the fact that many of these harmonized standards will become invalid by 21 March 2010 and will be replaced by new standards. Given this, these standards may no longer be used to assume compliance with the essential requirements of the Directive.

Please review the documentation of your medical devices to ensure that compliance with the essential requirements of the Medical Devices Directive is still maintained with the new editions of the harmonized standards. To continue to assume the compliance with the essential requirements of the Directive, revised or new requirements of these harmonized standards may have to be fulfilled.

The list of harmonized standards for general medical devices as per Directive 93/42/EEC can be found on the following web site:

http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/medical-devices/index_en.htm

The list of harmonized standards for active implantable medical devices as per Directive 90/385/EEC can be found on the following web site:

http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/implantable-medical-devices/index_en.htm

Disclaimer: This is a voluntary service provided by TÜV SÜD Product Service GmbH. While we analyse and interpret the relevant information very thoroughly, we accept no responsibility for the correctness of the information provided. Changes in the content of the interpretation on the part of the authorities are possible at any time.

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Reuters on 2/18/10 wrote about the well attended meeting by industry representatives.

FDA News Release on Feb 9, 2010 on subject.

The Wall Street Journal on FDA re-evaluation of their approval processes.

This issue we are going to focus on primarily on the MDD Amendment 2007/47/EC as the deadline to comply is very soon.  You must comply with the MDD Amendment 2007/47/EC as of March 21, 2010.  There is no transition period for the amendment to the MDD.  First, we are presenting an audio conference titled “Are You Ready for the MDD Amendment Directive 2007/47/EC” which will be on January 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 provide you with updated MEDDEV Guidance documents that have been updated to align with the Amendment to the MDD.  In addition to the above items to help you out you can also purchase our MDD Amendment Toolkit, which is only $249.00.

We will occasionally provide you with an Associate Profile so you can get to know some of our varied staff and some of their experience.  This edition we feature our newest Associate, Alf Dolan.

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.

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”.

View the press release on the NEMKO website.

Are You Ready for MDD Amendment Directive 2007/47/EC?

Wednesday Jan 27, 2010, 2:00pm – 3:00pm 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

Time is running out – ease your MDD compliance strategy stress with detailed guidance from Leo Eisner!

The revised MDD 93/42/EEC comes into effect on March 21, 2010 and the changes will impact all medical device manufacturers that CE mark their products or plan to do so in future. There is no transition date for the amendment 2007/47/EC and if you are not in line with these new requirements by the implementation date, you could lose your CE mark certificate from your notified body.

In this audio conference, Leo Eisner provides an overview of the changes to the MDD, including: changes to definitions, the essential requirements, technical documentation requirements, classification rules, labeling requirements, and new requirements for usability (user error) and clinical data. The presentation also covers how the New Machinery Directive and the Personal Protective Device Directive work in concert with the MDD Amendment.

This audio conference covers:

• Major areas of change in the amended Medical Device Directive
• The drivers for this change
• Things your notified body may ask for during an audit
• Determining what areas of your system may be impacted
• The interplay between the revised MDD and other EU directives

Who should attend?

• Regulatory Affairs
• Quality Assurance
• Operations/Manufacturing
• Managing Directors
• Senior Management

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

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.”

Medical Device Technology article in the Nov/Dec ‘09 publication of MDT on a new single component isolation device for USB for medical device application.

You can read the article by clicking here.  This link has also been added to Links page in the Compliance Resources section.

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.