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Philadelphia Chapter: Overview of MDR Changes and the Impact Outside the EU

RAC Credits
Tuesday, 22 October 2019 (5:30 PM) - Tuesday, 22 October 2019 (8:30 PM) Eastern Time (US & Canada)
425 Commerce Dr
Fort Washington, Pennsylvania, USA, 19034-2713

Member: $20
Nonmember: $30

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.

The new regulation introduces more stringent clinical and post-market surveillance requirements for medical device manufacturers, regardless of risk classification. Come join others from your local regulatory community to learn strategies that can help your device company navigate the higher level of scrutiny. Topics to be covered will include:

 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

 Impact of EU MDR Outside EU

  • What Changes are Required to Devices per MDR?
  • What Type of Changes Impact Countries Outside the EU?
  • What are International Country Impacts?
  • What are Timelines for Approvals?
  • Company has decided to Rationalize – Now What?

This event, hosted by Temple University, is coordinated by the RAPS Philadelphia chapter and is intended to encourage knowledge sharing and community development. Dinner will be provided for all attendees, compliments of Network Partners, and RAC holders may claim two RAC recertification credits.

Featured speakers:
Tamas Borsai, audit manager, TÜV SÜD America
Ratinder Dhami, director of regulatory affairs at Network Partners