EU Medical Device Changing Regulatory Landscape; 2010 Changes Now and What Current Re-writes Hold fo (Medical Training)
Venue: Online Event
|Event Date/Time: Nov 22, 2010||End Date/Time: Nov 22, 2010|
Upon completion of this webinar attendees will have a thorough knowledge of the 2009-2010 changing requirements for developing and marketing Medical Devices in the European Union. In addition, the Medical Device Directives and CE Marking Registration system is currently undergoing another major overhaul by the European Commission. We will focus on the current and predicted future requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the likely new requirements of CE Marking and ISO Certification on commercializing Devices.
Attend this webinar to learn the problems that exist with the current EU system and the options that the Commission is considering as they re-write the New Legislation which is scheduled to surface in late 2010 or early 2011. 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.
Areas Covered in the Seminar:
The purpose of the Medical Device Directives.
The current regulatory situation in relation to Medical Devices in the EU and the changes coming into force in 2010 from Directive 2007 / 47 / EC.
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.
The current EU challenges with the CE Marking process, Auditing by Notified Bodies and Under-reporting of Device Adverse Events.
The Options the European Commission have to fix the current Problems.
Feedback the Commission has received from Stakeholders.
What this feedback likely means for future Directive changes and Member State Legislation.