On 5 May 2017, the European Commission adopted the new Medical Device Regulation (MDR) 2017/745. There is a three-year transitional 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 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 to learn strategies that can help your device company navigate the higher level of scrutiny, including:
- Key differences between the new regulation and the directives it replaces
- Data from clinical investigations vs. literature review
- The concept of equivalence
- The additional scrutiny in the pre- and post-market phase
- MEDDEV 2.7/1 rev. 4 as a possible first step to compliance with the MDR
- How to ensure a smooth transition to MDR certification
This program, hosted by Hu-Friedy Mfg. Co., LLC
, is brought to you by the RAPS Chicago Chapter and is intended to promote knowledge sharing and engagement with others in the local regulatory community. Dinner will be provided and RAC holders may claim two RAC recertification credits.
Dr. Bassil Akra, vice president, global focus teams, TÜV SÜD
RAPS Members: $30