Your EU MDR Journey Continues: An Insight Into Strategic Approaches For Collecting Clinical Evidence In The Post-Market Era, Upcoming Webinar Hosted by Xtalks
In this free webinar, the featured speakers will discuss the available data collection methods in the post-market phase and the extent to which ISO 14155 should be used as the standard for clinical investigation in the post-market phase. Attendees will learn to leverage premarket clinical investigation data in the post-market phase as well as key considerations in terms of data privacy/informed consent in the post-market phase.
TORONTO, Ontario, Aug. 11, 2020 /PRNewswire-PRWeb/ -- In this webinar, the panelists will continue the journey of medical devices, i.e. from the moment the device got access to the EU market and onwards. On the one hand, this webinar will help you to understand the requirements defined in a number of regulations, standards and guidelines (see below). On the other hand, and likely even more important, this webinar will guide you on how to act upon these requirements. Our experts will share their thoughts and strategic considerations to efficiently continue clinical evidence data collection in the post-market phase. Questions will include: "What clinical evidence do I have access to?", "What type of data collection methods can I consider?", and "What else do I need to stay on the market?". The questions will be answered with appropriate context, all with the goal of helping participants navigate during the continuous journey of their medical device.
Since the adoption of the European Medical Device Regulation (MDR) 2017/745 in 2017, several guidance documents have been published by the Medical Device Coordination Group (MDCG). Although these documents may not be legally binding, it is strongly recommended to follow them closely, as they aim to ensure uniform application of the MDR within the EU. Recently, a number of guidance documents referring to clinical investigation and evaluation became available. In parallel, the European Data Protection Board regularly publishes guidelines, recommendations, and best practices that should be taken into consideration when collecting clinical data. A combined knowledge of the EU MDR, above-mentioned guidance documents and guidelines, and associated MEDDEV guidelines provides manufacturers with the essential information with respect to the collection of clinical evidence medical devices; it is an evident challenge to connect all the bits and pieces.
Join Alwin van den Broek, Project Manager and Data Protection Officer, Avania and Anne Leijsen, Director, Medical Writing, Avania in a live webinar on Friday, August 28, 2020 at 10am EDT (3pm BST/UK).
For more information or to register for this event, visit Your EU MDR Journey Continues: An Insight Into Strategic Approaches For Collecting Clinical Evidence In The Post-Market Era.
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