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IMPACT OF THE REGULATIONS ON SUBSTANCE-BASED MEDICAL DEVICES
Session Chair(s)
Miranda Moussa, PharmD
Johnson & Johnson, Belgium
In light of the growing interest in substance-based medical devices across Europe, the session will look into their particularities and consider ways to ensure that safe, effective and innovative substance-based medical devices continue to reach citizens. The latest European developments on the proposed regulation on medical devices and their potential impact on this category will be discussed.
Speaker(s)
A Notified Body’s Perspective on the Impact of the Proposed Medical Device Regulation on Substance-based Medical Devices
Neil Adams, PhD
BSI, United Kingdom
Director Operations and Delivery, Medical Devices
Adjusting the Medical Device Legislation to Substance-based Products- The perspective of one competent authority
Judite Neves, PharmD
Infarmed, Portugal
Head of Health Products Directorate
The Self-Care Industry Perspective on the Impact of the Proposed Regulation on Substance-Based Medical Devices
George Jessen
Procter & Gamble, United Kingdom
Regulatory Affairs Mananger
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