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Virtual Program: Key Challenges in Preparing for EU Medical Device Regulation (MDR)
Dec 6, 2018 from 11:00 AM to 4:00 PM
6 December 2018
11:00 – 4:15 pm EST
Register by 28 Nov
RAPS Members: $ 399
Nonmembers: $ 460
Register after 28 Nov
RAPS Members: $ 499
Nonmembers: $ 575
The new European Medical Devices Regulation (MDR) was published in May 2017 to improve the safety and efficacy of medical devices in the EU. This regulation replaces two of the existing medical device directives by 2020. The transition window for compliance with MDR is rapidly closing, manufacturers need to be making urgent progress in addressing changed requirements and generating supporting evidence needed to for both new and existing legacy CE Marked AIMD/MDD devices. Regulatory affairs professionals with responsibility for European devices can’t afford to wait until all the supporting guidance documents and expectations are fully clarified, it is important to make assessments now to anticipate how to address new requirements while there is still enough time to generate the information, balancing how much is expected to be enough with the expense of doing too much.
This program will be focusing on key areas requiring significant effort to evaluate and update to maintain access to the European marking such as understanding clinical data expectations, generating clinical evaluation reports, updating technical documentation and preparing for enhanced post-market requirements.
Understand the impact of the new clinical requirements on clinical evidence
Understand new expectations of clinical evaluation reports
Understand the technical documentation required to demonstrate compliance
Understand enhanced post-market expectations
Who Should Attend:
Medical device regulatory affairs staff responsible for compliance, submissions, clinical and post market of products intended for Europe
Consultants and suppliers supporting medical device regulatory affairs staff
Mindy McCann, vice president of regulatory compliance, Qserve Group
Keith Morel, vice president of regulatory compliance, Qserve Group
Additional Speakers TBA
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