This webinar will discuss the requirements for medical devices in the European Union, including the relevant directives, guidance documents, and processes for CE marking and ISO certification. It will cover topics such as the definitions and classifications of medical devices, conformity assessment, and the requirements for clinical investigations and evaluations. The webinar aims to help medical device professionals and others involved in registering devices in the EU to better understand and implement the regulations. It will be led by Robert J. Russell, an expert in global regulatory issues for medical devices.

1. Medical Devices: EU Directives, Guidance Documents, CE Marking Process and
ISO Certification Programs
December 16, Thursday 10:00 AM PST | 01:00 PM EST
Why Should You Attend:
This webinar is focused on understanding the requirements of the Medical Device Directives, their linkage to the EU
Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products. The course
covers all relevant topics in brief associated with the Directives and Guidance Documents, the reasons behind their
introduction and a review of methods for effective implementation.
Date: December 16, Thursday 2010
Time: 10:00 AM PST | 01:00 PM EST
Duration: 60 Min
Instructor: Robert J Russell
Location: Your office or conference room (no need to travel!)
Key Topics to be Discussed:
• The current regulatory situation in relation to Medical Devices in the EU.
• The purpose of the Medical Device Directives.
• Meeting the New Requirements for Conformity Assessment by Product Type.
• Understanding the impact the Directive will have on developing and marketing new Medical Device products.
• An overview of key areas of the Directive:
o Scope of application and definition
o Essential Requirements
o Medical Device Type & Process Path
o Medical Device Technical File
o Clinical Investigations
o Clinical Evaluations
o Notified Bodies
• Gain a detailed understanding of all Guidance Documents available to assist in the implementation of these directives.
Robert J Russell
Register Now

2. Detailed Agenda of the Session:
• Definition: Medical Device or Personal Protective Equipment.
• Overview of Global Medical Device Industry
o Standard
o Active Implanted
o In Vitro Diagnostic
o Combined Medicinal / Device- Interface with Other Directives
• An Overview of the Medical Device Directives.
o Development, aims, implementation and update of the Medical Device Directives
o Implication of an EU Directive vs. Regulation
o Medical Devices (MDD), Active Implanted Medical Devices (AIMDD), In Vitro Diagnostic Medical Devices (IVDMD), Combined
Medicinal / Medical Device Products
o Update on the additional guidance documents relating to the directives
o Essential Requirements
o Classification of MD's and Process Implications / Path by Device Type
o Conformity Assessment
o Technical File
o Relationship to EU Clinical Trial Directive
• Guidance Documents.
• Medical Device Directive Annexes.
o Compliance Requirements by Type
o Full Quality Assurance System
o Declaration of Conformity
• Safety.
o Medical Device Vigilance System
o Manufacturer's Requirements
+ GMP
+ GCP
+ CE Marking
+ ISO Certification
+ Clinical Trials
+ Labeling
• ISO Standard Certification.
o Overall process; Management Commitment & Involvement
o Role of Notified Bodies
o Relationship to CE Marking
o ISO-13485 (Manufacturing) & ISO-14155 (Clinical Investigation & Evaluation) Overview, Conformity, Auditing and Harmonization to
International Standards
• ISO-14155 Medical Device Clinical Investigations.
o Part I- Clinical Studies
o Part II- Clinical Investigations
o Linkage to EU Clinical Trial Directive; What Does & Doesn't Apply
• Compare & Contrast EU & FDA Procedures and Requirements.
o Process Similarities & Differences
• Implications for Industry
o Company Management
o Process Changes
o Management Team Effectiveness
• Regulatory Approval and Liaison with Regulators.
o EU Co-Decision Procedure
o Committees, Working Parties Relevant for Medical Devices
o When and How to Influence Regulators
o Do's and Don'ts of Regulatory Involvement
o Individual Company Involvement vs. Trade Association
• Practical Checklist of Activities; Effective Process Planning
• Case Studies; Individual Country Experiences

3. Learning Objectives:
Upon completion of this course attendees will have a thorough knowledge of the requirements for developing and
marketing Medical Devices in the European Union. The Directives are complex and the requirements differ somewhat
by Member State. The content of this course is designed to simplify the understanding of all requirements and to
provide attendees with the latest information regarding interpretation and enforcement of these regulations.
Who Will Benefit:
This workshop will be of great value to Medical Device professionals and those involved in the registration of Medical
Devices across the EU. It is primarily designed to benefit the following disciplines:
• Clinical research and medical operations
• Project Managers
• Product Development personnel
• Manufacturing personnel
• Researchers managing Medical Device R&D and Development
• Quality Assurance such as GMP, GCP Auditors
• Regulatory affairs
• Clinical trial supply personnel
• CRO personnel
• All personnel who need to understand the procedures and impact of placing Medical Devices on the Market in the
EU (25 expanded countries)
Instructor Profile:
Robert J. Russell, (Bob) is the President of RJR Consulting, Inc. RJR Consulting Inc. specializes in under-
standing global regulatory issues for the pharmaceutical industry. Bob has more than 25 years of experience
working with FDA and the Commission on technical issues as they relate to policy development, regulation,
clinical trial and the medical device development process.
Prior to entering the consulting field, Mr. Russell was the Global Director of Regulatory Affairs for two Fortune
100 firms. These companies were major raw material suppliers to the pharmaceutical and medical device
industry and one a joint-venture parent of a major pharmaceutical division.
Registration Information:
* Register Online. Use your American Express, Visa or MasterCard.
* For more than one attendee get 20% off on the price of additional attendee.
* Get your group to attend the webinar at a discounted price call +1- 650-620-3937.
* Call +1 - 650-620-3937 or Fax your PO: 650-963-2556.
* Mail your check to: ComplianceOnline (MetricStream, Inc), 2600 E. Bayshore Road, Palo Alto, CA 94303.
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