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

This webinar will be highlighting 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 a summary review of relevant topics associated with the Directives and Guidance Documents, the reasons behind their introduction and a review of the methods for effective implementation.Key topics to be discussed include:

• The current regulatory situation in relation to Medical Devices in the EU.
• The purpose and structure of the Medical Device Directives: Standard, Active-Implantables and IVDs.
• Recent Directive updates.
• 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
  • EU Classification Rules
  • Essential Requirements
  • Medical Device Type & Process Path
  • Medical Device Technical File
  • Clinical Investigations
  • Notified Bodies involvement
• Gain a detailed understanding of all Guidance Documents available to assist in the implementation of these directives.

Areas Covered in the seminar:

• Definition: Medical Device or Personal Protective Equipment.
• Overview of Global Medical Device Industry / Medical Device Types
  • 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. an EU 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
  • Review of Device Essential Requirements
  • Classification of MD's and Process Implications / Path by Device Type
  • Conformity Assessment Procedure Options
  • Technical File / Design History 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
• Regulatory Approval and Liaison with Regulators.
  • 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

Learning Objectives:

Upon completion of this course, attendees will have a thorough knowledge of the requirements for developing, marketing and meeting regulatory compliance requirements for Medical Devices in the expanded European Union. The Directives are complex, ever-changing and the regulatory 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 management and support personnel who need to understand the procedures and impact of placing Medical Devices on the Market across the European Economic Area (30 expanded countries)

Instructor Profile:
Robert J. Russell, For the past 9 years, Bob has been President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance. RJR has offices in Columbus, OH, Washington, DC, Brussels, Belgium with exclusive affiliates across Asia and Latin America. Bob has 28 years of past industry experience as a CMC specialist, R&D Director and Global Director of Regulatory Affairs for Merion Merrill Dow pharmaceuticals and Cordis-Dow medical devices. He has a BS / MS degree in Chemistry.