Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs - CD

This OnDemand Web Seminar is also Available on CD

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.

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:
  • Scope of application and definition
  • Essential Requirements
  • Medical Device Type & Process Path
  • Medical Device Technical File
  • Clinical Investigations
  • Clinical Evaluations
  • Notified Bodies
• Gain a detailed understanding of all Guidance Documents available to assist in the implementation of these directives.

Detailed Agenda of the Session:

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

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 understanding 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.

Training Duration = 60 Min

On Demand Online Access

• One Person - Unlimited viewing for 6 Months.
• For multiple licenses contact our customer care team.
• Recorded Link and Reference material
• Format: Webinar / access via the internet

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