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Anticipated Changes to the EU Medical Device Directives; 2010 Changes and What the Future Holds for Licensees

Instructor: Robert J Russell
Product ID: 702169
  • Duration: 90 Min

recorded version

$349.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$549.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

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Read Frequently Asked Questions

This Medical Device Directive training will discuss the recently implemented and currently planned changes to the Medical Device Directives across the EU. It includes specific insight from direct involvement and work within the EU and the Commission's major improvement objectives to their system today. Specific targeted areas for change is discussed as well as the likely implementation timetable.

Course "Anticipated Changes to the EU Medical Device Directives; 2010 Changes and What the Future Holds for Licensees" has been pre-approved by RAPS as eligible for up to 1.5 RAC credits towards a participant's RAC recertification upon full completion.

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 training will be discussing the recently implemented and currently planned changes to the Medical Device Directives across the EU. It includes specific insight from direct involvement and work within the EU and the Commission's major improvement objectives to their system today. Specific targeted areas for change is discussed as well as the likely implementation timetable.

Learning Objectives:

Upon completion of this course, attendees will have a thorough knowledge of the ever-changing landscape to the EU Medical Device Directives across 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 current requirements and to provide attendees with the latest insight to what the Commission believe are areas for improvement and what structure and requirements are likely to change.

Areas Covered in the Seminar:

  • 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:

  • 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
  • 2009-2010 Changes from Directive 2007 / 47 / EC
  • Current Perceived Problems (by the Commission) with the Current CE Marking Registration System and Notified Body Auditing Structure
  • Correction Options Laid Out by the European Commission
  • Feedback Received from Stakeholders
  • What this Feedback likely Means for Future Directive Changes, Member State Legislation and Implementation Timing

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 across the EU

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.

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