Ensuring Compliance with Medical Device Directive Revisions: Training Course

Understanding MDD Revisions to Essential Requirements, and Changes to Clinical Requirements from the Notified Body, Competent Authority, and Industry Perspective

February 15, 2010
Munich, Germany

 

As the deadline to comply with the latest Medical Device Directive revisions is quickly approaching, many medical device companies are scrambling to meet the new equirements. Although the most recent revisions were released in early 2007, full compliance with the directives is not required until March 21, 2010. With this deadline looming, manufacturers, notified bodies, and competent authorities are all working towards ensuring full compliance with the new interpretations and revisions. Understanding what the revisions mean for each specific medical device product and company is critical in ensuring continued compliance with regulations impacting documentation, certification, clinical evidence and post market follow through, to name a few. New classifications of devices are also of concern to many medical device manufacturers as they address regulations that have not previously governed their products. This one-day training course will provide both US and European based manufacturers with panel discussions and a clearer understanding of the interpretations from the perspective of manufacturer, notified body, and competent authority.

 

Key aspects that will be addressed during this workshop include changes to the clinical requirements, re-classification of devices, and panel discussions addressing the current interpretation of the new regulations.

 

Throughout the program, which will feature presentations and panel discussions led by industry experts and authorities, manufacturers will find hands-on learning opportunities for a final compliance check.  Speakers will emphasize the key challenges with the latest MDD Revisions, providing guidance on what must be achieved to remain in line with the revisions.

Topics to be Covered

 

• Overview of the Changes to the Clinical Requirements within the Medical Device Directive
  
• Understanding the Re-Classification of Devices Under the New Directive
  
• Interpretation of Changes to the Essential Requirements
  
• Expectations from a Competent Authority Related to the New Revisions
  
• Case Study: Example of a Successful Submission within the New Directive
  
• Expectations from Notified Bodies in Relation to the Revised Regulations
  
• Assessment of Technical Files
  
• Adverse Event Documentation

Course Facilitators

 

Gert Bos, PhD, Head of Regulatory and Clinical Affairs, BSI

 

Dr. Stefan Mezl, Director of Regulatory Affairs & Compliance, Abbott Medical Optics (AMO)

 

Ron Nash, Technical Manager, Intertek

 

Dr. Dirk Wetzel, Competent Authority, Federal Institute for Drugs and Medical Devices, Germany

 

Rainer Voelksen, Regulatory and Quality Executive, European Region, GE Healthcare

 

Information

 

Download Agenda

 

To request registration details and information on promotional pricing please contact:
Paul Hernandez, Marketing Manager
phernandez@Q1productions.com
312-602-9684