Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Program
|Event Date/Time: Oct 04, 2011||End Date/Time: Oct 04, 2011|
This Medical Device training will be discussing the newly-updated requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and 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 contemplated changes coming on the EU Medical Device Directives.
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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 Device Requirements
Medical Device Type & Process Path
Medical Device Technical File
Clinical Investigation Requirements
Notified Bodies involvement
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
In Vitro Diagnostic
Combination Products; Drug or Biologic + Device- Interface with Other Directives and How Itâ€™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
Classification of MD's and Process Implications
Relationship to EU Clinical Trial Directive
Medical Device Directive Annexes.
Compliance Requirements by Type
Full Quality Assurance System
Declaration of Conformity
Medical Device Vigilance System
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
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
Upon completion of this course attendees will have a thorough knowledge of the requirements for developing and marketing Medical Devices 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 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
Product Development personnel
Researchers managing Medical Device R&D and Development
Quality Assurance such as GMP, GCP Auditors
Clinical trial supply personnel
All personnel who need to understand the procedures and impact of placing Medical Devices on the Market in the EU (30 expanded EEA countries)
About the Speaker:
Robert J. Russell, is President and CEO of RJR Consulting, Inc, a leading Global Regulatory Consulting firm focusing on assisting the Life Science Industry. Prior to founding the firm in 2000, Mr. Russell had over 27 years of experience in CMC, Global Business Development and Regulatory Compliance for pharmaceuticals, biologics, medical devices and combination products. The company has an office in Brussels, Belgium where they interact with the European Commission and the Competent Authorities across the EU. Country establishment, marketing authorizations, variations and license renewals are core competencies of the course director. Mr. Russell has received a B.S. and M.S.in Chemistry.