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CURRENT STATUS OF REVISION OF EU MEDICAL DEVICE DIRECTIVES: THE KEY THEMES AND CONTROVERSIES
Session Chair(s)
Shayesteh Fürst-Ladani, MBA, MS
CEO
SFL Regulatory Affairs & Scientific Communication, Switzerland
The EU’s three main medical device directives are being revised into two Regulations. The first will cover active implantable medical devices and medical devices in general in one text, the second will regulate IVDs. This first session will assess the main changes of the texts that were issued as draft revisions in September 2012, the reaction of stakeholders, including industry, and assess the debate ahead as the text is reviewed by the European Parliament and Council.
Speaker(s)
Overview from the European Commission: Immediate measures for medical devices ensuring patients’ safety
Erik Hansson
European Commisison, Belgium
Deputy Head of Unit, Health Technology and Cosmetics
Overview of the Main Changes Being Introduced in the Revision of the Medical Device Directives
Shayesteh Fürst-Ladani, MBA, MS
SFL Regulatory Affairs & Scientific Communication, Switzerland
CEO
A Member State’s View (NL) on the Revision of the Medical Devices Legislation: Work in progress at Council’s level
Danielle Mulukom
Ministry of Health, Welfare and Sport, Netherlands
Senior Advisor, Department of Pharmaceutical Affairs and Medical Technology
Most Contentious Issues for Industry Surrounding the Revisions: Predicted impact on innovation and likely battles ahead at the European Parliament and Council
Dario Pirovano
Eucomed, Belgium
Consultant - Regulatory and Technical Affairs
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