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...
TORONTO (PRWEB) July 16, 2020
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.
The featured experts will provide their thoughts and considerations on getting 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 attendees 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 attendees with the full journey throughout the clinical lifetime of the device.
For more information or to register for this event, visit The Journey from Final Medical Device Design to the EU Market: Expert Insight on Collecting and Evaluating Clinical Evidence.
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