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 in respect to the collection of clinical evidence of non-marketed devices — it is an evident challenge to connect all bits and pieces.
In this webinar, we will take participants through the journey from their final medical device design to the EU market, according to the requirements set forth in the regulations and guidelines outlined above. Our experts will provide you their thoughts and considerations to get a solid clinical development strategy in place. From the very first question (“What clinical evidence do I need?”), toward a study design (“What type of study design shall I consider?”), until the evaluation of the clinical evidence (“Am I ready to access the market?”). Each of these topics will be discussed, taking sidetracks as necessary to help you understand the decisions that are to be made — but also to get you on board for the remainder of the journey.
This webinar will be part of a series. Whereas the main focus of this webinar refers to the premarket phase, the subsequent 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 to 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 joined Avania after finishing his master’s degree in human movement sciences over 10 years ago. His early years in the industry were dedicated to European clinical investigations supporting CE marking, bringing the technologies to the “bedside.” In his current roles as project manager and data protection officer, he supervises and directs project teams to ensure that startups 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’s degrees in neural engineering and biomedical engineering over five years ago. She has a solid background in conducting, designing, and analyzing clinical studies. With her strong expertise in regulatory requirements with respect to collecting and evaluating clinical evidence, she guides medical device manufacturers toward the most efficient (by time or cost) clinical strategy. As the director of medical writing, she is responsible for managing medical writing services (including clinical evaluation conduct, clinical protocol development, and manuscript writing) 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 with respect to 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 the key requirements with respect to clinical evidence in the EU?
- How do you identify key milestones in your clinical development strategy?
- How do you use a risk-based approach for the design of your clinical study?
- What can be considered as a relevant source of clinical evidence in the premarket 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.