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Self-Care Medical Devices: Shifting Borders between Devices and Pharma?
Session Chair(s)
Anja Wiersma, PHD
CEO and senior consultant
Mi-Ce Consultancy, Netherlands
In this session the impact for substance based medical devices of the upcoming new Medical Device Regulation (MDR), such as the new definition of pharmacological means and classification rule 21, will be discussed. Both regulators’ and regulated industries’ perspectives will be shared. As an example of best practice, the national regulatory controls on these products in the Netherlands will be highlighted.
Learning Objective : -Provide background information on the self-care medical devices sector, -Understand the specificities of substance-based medical devices, notably their classification, the general and safety and requirements specific to these devices and transitional period provisions; -Discuss the latest European developments on the proposal for a regulation on medical devices.
Speaker(s)
Substance-Based Medical Devices: Perspective from a Regulator
Judite Neves, PHARMD
Infarmed, Portugal
Head of Health Products Directorate
Substance-Based Medical Devices: Perspective from Regulated Industry
Miranda Moussa, PHARMD
Johnson & Johnson, Belgium
National Regulatory Control on Substance-Based Medical Devices in the Netherlands
Vincent Bouwmeester
Keuringsraad KOAG-KAG, France
Project Manager