Medical Devices - EU Directives, Guidance, CE Marking and ISO Standard Certifications

This workshop will be of great value to clinical research professionals and those working with them involved in carrying out clinical trials. 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)

Learning Objectives

Upon completion of this course you 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. This content of this course is designed simplify the understanding of all requirements and to provide the attendee with the latest information regarding the interpretation and enforcement of these regulations.

Course Description

A two-day workshop focusing on understanding the requirements of the Clinical Trial 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 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 E U.
 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 and field 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 implementation of these directives

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COURSE AGENDA

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 and planned implementation of the Medical Device Directives
• Implication of 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