Sponsors involved with medical device design and development in the EU have rapidly diverted efforts to projects enabling increased production of essential devices during the current COVID-19 Pandemic. Understandably, the medical device industry is unable to focus efforts towards the fast-approaching current date of application of Regulation (EU) 2017/745 on medical devices (MDR) of 26 May 2020.
On 3 April 2020, the European Commission published the proposal, “Regulation of the European Parliament and of the Council: amending Regulation (EU) 2107/745 on medical devices as regards the dates of application of certain of its provisions” proposing a one-year delay to MDR compliance (26 May 2021).
Access this on-demand webinar to learn how Sponsors can take advantage of the extended timeline for MDR conformity. Discussed will be how a combined approach between Clinical Management and Biostatistics can assist device makers efficiently meet clinical evidence requirements under MDR. In addition, three separate case studies that highlight potential study designs and the use of statistical methods to mitigate risk and accelerate clinical timelines will be reviewed.
Webinar participants will leave with a better understanding of:
- How to define and optimize a strategy to be complaint with clinical evidence requirements
- What study designs should be considered for pre- and post-market studies, and how they can be optimized with an early biostatistical approach
- What regulatory insights are available for study submissions across the EU, and what could change with MDR