Eisner Safety Consultants

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This page includes some of the documents and web resources that we rely on to do our every day regulatory & compliance work.  We hope you find these resources helpful.  Another place to check out is our weblinks page that has additional resources we rely on.  Please contact us with any suggestions for additional links or if you find any broken links.

• Medical Device Directive (MDD) Consolidated Version (includes revisions up to September 2007)
• EC Interpretative Document on the Implementation on the MDD & AIMDD Amendment 2007/47/EC
• List of Harmonized Standards for the MDD
• Team Notified Body (Team NB) Report on EU Languages for MD, AIMD, & IVD Directives July 2007
• Medical Device Directive Guidance Documents (MEDDEVs)
  • Boderline Products MEDDEV 2.1/3 revision 3
  • Classification MEDDEV 2.4/1 revision 9
  • Clinical Evaluation MEDDEV 2.7/1 revision 3
  • Vigilance Reporting MEDDEV 2.12/1 revision 6
• Notified Body Recommendations (MDD)
• Active Implantable Medical Devices Directive (AIMDD) Consolidated Version (includes revisions up to September 2007)
• EU Medical Device Sector Information Web Page – Includes links to implementing legislation, re-classifications, Guidance, Consensus statements, Standards and Interpretative documents, and Vigilance Reports
• In vitro Diagnostic Directive (IVDD) (includes revisions up to September 2003)
• Restriction of the use of Certain Hazardous Substances in Electrical and Electronic Equipment Directive (RoHS) Consolidated Version
• Waste Electrical and Electronic Equipment Directive (WEEE) Consolidated Version