Webinar: Clinical Evaluation Requirements under European Medical Device Regulation: Impact on Businesses, and Brussels Update
18 January 2018
MassMEDIC held a free webinar on 18 January 2018 on the subject of 'Clinical Evaluation Requirements under European Medical Device Regulation: Impact on Businesses, and Brussels Update', attend by nearly 200 people.
The European Medical Device Regulation (MDR; EU 2017/745), which becomes mandatory on 26 May 2020 (date of application), introduces requirements on clinical evaluation that were previously only in European guidance. Compliance with these requirements will have a direct effect on the CE marking process and the ability of companies to avoid future disruption of their devices being maintained or placed on the European market. This webinar provided an overview of clinical evaluation requirements, emphasizing those requirements likely to have the most significant impact on small, medium and large medical device companies. A brief update on European-level activities needed for implementation of the MDR was also provided.
The speaker was Maria E. Donawa, MD, President, Donawa Lifescience Consulting.