CE Marking: Obtaining and Maintaining EU Compliance Under the Medical Device Directive

Instructor: Jeff Kasoff
Product ID: 701789
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556


Read Frequently Asked Questions

This CE marking training will discuss the recent changes to MDD (Medical Device Directive), how to identify non compliance areas, contents of the technical file and essential requirements document and how to select notified bodies for MD compliance.

Why You Should Attend:

Medical devices cannot be shipped to Europe unless they are in full compliance with the Medical Device Directive. The compliance burden is very different depending on the classification of the device.

This session will cover the Technical File and Essential Requirements document, in which design documentation must be maintained; unless you are intimately familiar with the requirements in advance, this could be a serious compliance issue. Also contained will be the recent changes to the MDD, noncompliance with which opens the possibility of cessation of certification. Also, unlike domestic (US) regulations, the MDD requires clinical data - methods for gathering this data will be reviewed. Notified body selection is a critical aspect of MD compliance - this webinar will share some tips and provide experience in this area.

Areas Covered in the Seminar:

  • Device classification distinctions, and what that means to you in terms of compliance burden.
  • Technical File contents and organization.
  • Review and selection of your notified body.
  • How to show compliance with the Essential Requirements.
  • Changes to MDD and their implications.
  • What is expected for clinical data.

Who Will Benefit:

This webinar will provide valuable assistance to all device manufacturers who wish to sell product in the European Community. The employees who will benefit include:

  • Top management
  • Regulatory management
  • Quality Management
  • Sales and Marketing Management
  • Quality Engineers
  • Other personnel involved in development and implementation of the QMS

Instructor Profile:

Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate compliance with domestic and international regulations, preparation of submissions, and is primary liaison with regulatory agencies and notified bodies. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.

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