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

This workshop will be of great value to clinical research professionals and those 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 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.

Course Description

This is 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 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 implementation of these directives