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, abovementioned 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.
This webinar is part of a series. Whereas the main focus of the previous webinar (August 4) referred to the premarket phase, this webinar will have a post-market focus. Both webinars can be attended separately, and knowledge of the other webinar is not required. However, as Aristotle already pointed out, the whole is greater than the sum of its parts! Attendance of both webinars will provide you the full journey throughout the clinical lifetime of the device.
Alwin van den Broek, Project Manager and Data Protection Officer, Avania
Alwin van den Broek is currently project manager and data protection officer, where he supervises and directs project teams to ensure that start-ups and well-established medical device companies gather clinical evidence in compliance with applicable standards (including ISO 14155), guidelines, and (local) regulations. Guiding medical device companies toward a strong strategic regulatory path is driven by his special interest in the European regulatory framework and the GDPR.Message Presenter
Anne Leijsen, Director, Medical Writing, Avania
Anne Leijsen joined Avania after finishing her Master of Neural Engineering and Biomedical Engineering over five years ago. She has a solid background in conducting, designing and analyzing clinical studies. As the director of medical writing, she is responsible for managing medical writing services including clinical evaluation conduct, clinical protocol development and manuscript writing while working within an experienced team of medical writers and proactively providing client services where needed or requested. Leijsen has a special interest in the global regulatory framework, with direct expertise regarding the EU MDR and associated guidelines.Message Presenter
Who Should Attend?
- Regulatory Affairs Associate/Manager/Director
- Medical Affairs Associate/Manager/Director
- Clinical Development Associate/Manager/Director
- Clinical Operations Manager/Director
- Clinical Research Associate
- Medical Writer
What You Will Learn
- What are available data collection methods in the post-market phase?
- To which extentshould ISO 14155 be used as standard for my clinical investigation in the post-market phase?
- How can I leverage my premarket clinical investigation data in the post-market phase?
- What arethe key considerations in terms of data privacy/informed consent in the post-market phase?
Avania is an integrated global, full-service CRO with specialized expertise in medical device, novel technology, and combination products. They advance products from feasibility all the way through post-approval trials in analytics, clinical trials, consulting, regulatory, reimbursement, and more.