Philadelphia Chapter: MDR Impact on Reporting and Core Elements of CER Creation

RAPS Member: $30
Nonmember: $40
Temple Students: Contact RA/QA University Staff

A historical moment for the medical device industry occurred on 5 April 2017, as the Medical Device Regulation (MDR) 2017/745 was adopted by the European Union. The three-year transition period ends in May 2020, after which the regulation becomes law.

Come engage with professionals from your local regulatory community for an interactive presentation on the impact of MDR on clinical evaluation reports (CERs) and understand the core elements of CER creation, from document collection to the benefits of a highly collaborative writing and review process. Tips, tricks, “watchouts,” do’s and don’ts will be woven throughout the presentation. Topics that will be covered include:

• Understanding fundamental changes for clinical data requirements between the Medical Device Directive (MDD) and MDR
• Identifying key differences on risk classification of medical devices with the new regulation 
• Determining sufficient clinical data for a medical device
• Demonstrating equivalence and the possibility of CE marking
• Tackling complex issues such as multiple routes of conformity, multiple products or simple instruments
• Highlighting fundamental CER requirements as outlined in Annex XIV
• Learning the assessment of clinical data or state of the art literature under MDR  

This event, hosted by Temple University, is brought to you by the RAPS Philadelphia Chapter to encourage knowledge sharing and community development. A light meal will be provided for all attendees, and RAC holders may claim two RAC recertification credits.

Speakers:
Matthias Fink, MD, clinical reviewer, Clinical Center of Excellence, TÜV SÜD 
Joshua Samuels, PhD, senior manager, medical operations, Depuy
Angela Siebeneck, director of medical writing, Network Partners