Medical Devices: EU Directives, CE marking, ISO Certification and the NEW Device Regulations coming to the EU

Why Should You Attend:

This Medical Device training will be discussing the newly-updated requirements of the Medical Device Directives and their linkage to the European requirements for CE Marking and ISO Certification on commercializing products. The history, current processes and latest regulatory environment on all Classes of Medical Devices and Combination Products will be discussed. Learn how to classify your product and how that classification translates to the required data needed to CE mark your product across the EU. You will also be updated on the recent and changes coming for the two NEW EU Medical Device Regulations, recently announced for final roll-out in 2017.

This course is focused on understanding the requirements of the Medical Device Directives / Regulations, their linkage to the EU Clinical Trial Regulation 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 the Global Medical Device Industry
• Standard
• Active Implanted
• In Vitro Diagnostic
• Combination Products; Drug or Biologic + Device- Interface with Other Directives and How It’s Treated from a Regulatory Perspective
• 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), Combination Products
• Update on the additional guidance documents relating to the directives
• Essential Requirements
• Classification of MD's and Process Implications
• 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
• 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
• When and How to Influence Regulators
• Do's and Don'ts of Regulatory Involvement
• NEW EU Medical Device Regulation
• Impending Changes expected in the two NEW Device Regulations

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)

Robert J Russell
President, RJR Consulting, Inc

For the past 9 years, Robert J. Russell 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.

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