By : Compliance Online
Date : 2012
Location : United States US / Palo Alto
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.
EU Medical Device Directives, EU MDD, 2010 EU MDD Changes, EU CTD, CE Marking, ISO Certification
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.
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.
- Definition: Medical Device or Personal Protective Equipment
- Overview of Global Medical Device Industry
- An Overview of the Medical Device Directives
- 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
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.
Organizer : Compliance OnlineComplianceOnline is a Regulatory Affairs Professionals Society(RAPS) RA Professional Development Portal provider. ComplianceOnline is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs ComplianceOnline has agreed to follow RAPS-established operational and educational criteria