On 5 May 2017, the European Commission adopted the new Medical Device Regulation (MDR) 2017/745. There is a three-year transition period, ending in May 2020, after which the regulation will take effect. Device manufacturers have the duration of this transition period to update their technical documents and processes to meet the standards.
Come engage for a double session with professionals from your local regulatory community for an interactive presentation on how to prepare for the implementation. The new regulation introduces more stringent clinical and post-market surveillance requirements for medical device manufacturers, regardless of risk classification. Come join us and learn strategies that can help your orthopedic device company navigate the higher level of scrutiny.
Session I – Overview of MDR Changes:
- when legacy products need to be evaluated
- acquisition of companies with existing products on the market
- difference between the EU and FDA requirements concerning technical documentation
- difference between notified bodies
- transferring challenges of products from one notified body to another
- changes in the regulation
- areas of higher expectations
Session II – Overview of Clinical Requirements:
- key differences between MDR and MDD regarding clinical evaluation
- data from clinical investigations vs. data from literature review
- relevant changes regarding the demonstration of equivalence
- the additional scrutiny and requirements in the pre and post-market phase
- MEDDEV 2.7/1, Rev. 4 guidance document toward the transition from MDD to MDR
This event is coordinated by the RAPS Florida chapter and is intended to encourage knowledge sharing and community development. Continental breakfast will be provided, compliments of EMMA International Consulting Group Inc., and RAC holders may claim two RAC recertification credits.
Matthias Fink, MD, clinical reviewer, Clinical Centre of Excellence at TÜV SÜD
Max Singh, PhD global manager for Orthopedics, TÜV SÜD
RAPS Members: $20