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Regulatory Framework for Medical Devices in Europe
Session Chair(s)
Andrzej Rys, MD
Principal Scientific Advisor
European Commission, European Union, Belgium
In this session, we will provide an overview about the current regulatory framework in Europe for clinical trials with medical devices, highlighting similarities as well as differences to describe the range of potential variability across Europe. In addition, although medical device notified bodies are accredited by a member state to assess whether a medical device conforms to the EU Medical Devices Directive, there has been an increase in regulators requesting and performing a review of the documentation and assessment already conducted by the notified bodies. The question is raised whether this increased concern represents a lack of confidence in the notified bodies’ assessment or if it is a renewed approach from the regulators to be involved in the safety assessment of a medical device.
Learning Objective : Recognize the current situation of regulatory requirements for clinical trials with medical devices in Europe; Discuss the challenges raised with the increased requests from the regulators to review documentation and assessments prepared by the notified bodies.
Speaker(s)
The Role of EMA Versus Notified Bodies in Ensuring Fulfillment of the Essential Requirements in the Medical Devices Directive
Farzana Hussain
Novo Nordisk A/S, Denmark
Regulatory Project Manager and Team Leader
Current Situation and Potential Future Development of Regulatory Requirements
Rainer Porrmann, PhD
Accovion GmbH, Germany
Head, Clinical Trial Regulatory Management - Western and Central Europe
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