Eisner Safety Consultants

Toolkit to help meet
Medical Device Directive Amendment 2007/47/EC
Only $249.00

The changes to the current EC Medical Device Directive (MDD) 93/42/EEC have become mandatory as of March 21, 2010.  All manufacturers of CE marked medical devices now must be in compliance.  There is no transition date for the amendment 2007/47/EC.  Eisner Safety Consultants in conjunction of Roberts Consulting & Engineering is offering a package for device manufacturers to assist them in complying with the changes.  To order the package click on the Buy Now button.

The CD package contains the following useful resources to make your job easier in meeting the new changes in a timely and efficient manner:

1. Suggested project plan for transition to the amended MDD.
2. Gap Analysis Checklist as a self-assessment tool.  It identifies the changes and provides suggestions of how to address any gaps.
3. Two PowerPoint Training Presentations: A detailed review of the changes – can be used to train staff members that are directly involved in implementing the change.  An overview presentation – suitable for training all levels of employees.
4. Updated essential requirements (ER’s) checklist.  There are many changes & some reorganization of Annex I ER’s.  Use this to revise your technical files or dossiers.
5. Declaration of conformity (DoC) template.  There are some changes to the expectation of the contents in the DoC.  It is expected new DoC’s will be required for all products to state compliance with the directive as revised by 2007/47/EC.  These will need to be in place by March 21, 2010.
6. Clinical data SOP & report template.  The revised MDD requires all classes of device have clinical data.  The SOP is based on MEDDEV 2.7 and includes templates for a literature search protocol and a clinical data literature report.
   The revised MDD also requires that clinical data be updated over time.  The clinical data SOP addresses this by including requirements for Post Market Clinical Follow Up per MEDDEV 2.12-2.
7. Usability SOP & report template.  A major change to the ER’s is that the user of the device must be taken into account.  A usability analysis will need to be performed.  The SOP provides instructions for this and a template for the analysis process, which needs to start in the concept stage.

The documents are in Word 2003 or PowerPoint 2003 formats depending on the document.

This exciting new package is now available for $249.00.  You can order with a credit card or a Paypal account.  Once the purchase is processed we will send you an e-mail with all the documents in a zipped file format.

Note: No Purchase Orders will be accepted only payment using Paypal.