Meet & Greet with Gert Bos at the RAPS event: The Impact of the EU MDR on Legacy Devices

November 07, 2018 - November 08, 2018 / Europe

Date & time:  7 November | 09:00 AM  &  8 November | 15:00 PM

Location: Park Plaza Victoria Amsterdam, Damrak 1-5, 1012 LG, Amsterdam

The EU MDR significantly changes the regulatory framework for placing any new medical device on the market, but it does not provide any specific instruction for applying the new requirements to legacy devices with valid certifications under the MDD. Legacy devices can no longer be “grandfathered” into compliance and the implications are significant, from updating technical documentation to changing product labels and demonstrating robust clinical evidence. Manufacturers must start considering their transition plan for applying these new requirements to keep their devices in the EU market. 

This workshop is aimed at the mid-level regulatory affairs professional who is responsible for applying the EU MDR requirements to his/her organization’s products. Knowledge of the MDD is not required but does help provide a better understanding the of the impact of the changes on legacy products and will enable attendees to leave the workshop with a clearer path for creating the transition plan. 

Visit the original website for the full program details and registration.

Gert W. Bos, PhD, Fraps
Post date: September 06, 2018
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