Newsletter Summary

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.

• Newsletter Summary
• MDD Amendment 2007/47/EC Audio Conf. $50 Off
• MEDDEV Guidance Updates to Align to MDD Amendment
• Are You Prepared For The MDD Amendment Changes? Less than 2 Months Left
• Associate Profile - Alf Dolan

MDD Amendment 2007/47/EC Audio Conference
$50 off - Only $199

This audio conference titled “Are You Ready for MDD Amendment Directive 2007/47/EC?” is hosted by FX Conferences. The material will be presented by Leo Eisner of Eisner Safety Consultants. The audio conference is Wednesday January 27, 2009 from 2 – 3PM 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.

MEDDEV Guidance Updates to Align
with MDD Amendment 2007/47/EC

The three MEDDEV documents were updated recently, primarily to align with the MDD Amendment 2007/47/EC. The revised MEDDEVs will be applicable effective 21 March 2010. These documents can be found on the Library Page of Eisner Safety Consultants website.

• Borderline Products (MEDDEV 2.1/3, revision 3) – This guidance incorporates changes made to align with the Amended MDD. Some of the examples used in the 2^nd revision have not been included in this revision but additional examples may be found on the Europa borderline website (see footnote 1 of MEDDEV 2.1/3)
• Clinical Evaluation (MEDDEV 2.7/1, revision 3) - This guidance incorporates changes made to align with the Amended MDD and has transposed into the European context the Global Harmonization Task Force international regulatory guidance document on clinical evaluation (SG5/N2R8:2007).
  Eisner Safety Consultants can assist in the preparation of Clinical Literature Evaluations. Evaluation of Clinical Data per MEDDEV 2.7.1 to meet the requirements of the MDD/AIMDD
• Vigilance System (MEDDEV 2.12/1, revision 6) – This revision incorporates technical modifications to Annex 3 (Manufacturer’s Incident Report Form).

Associate Profile
of Alf Dolan

Alf Dolan, has been with Eisner Safety Consultants for almost a year. He has been involved in standards development for about 35 years in Canada and internationally for about 15 years. His focus has been with Electro-medical devices and risk management. He is the Convener of the Joint IEC/ISO Working Group 1 on the Application of Risk Management to Medical Devices, a joint working group between IEC Subcommittee SC 62A and ISO Technical Committee TC 210. This is the committee that published the world wide standard for all medical devices, ISO 14971; Risk Management for Medical Devices. Alf is also Chairman of the IECEE ME Task Force and is charged with developing the implementation requirements for risk management certification in IEC 60601 Medical Electrical Equipment for the IEC CB Scheme.

So, if you need assistance with Risk Management per ISO 14971 or understanding 3^rd edition of IEC 60601-1 Alf along with several other associates will be able to assist you with these issues. To see more of our associate go to our associates page.