Atlanta Chapter: Impact of the MDR Regulatory Changes on the EU Approval Process

When:  Sep 26, 2018 from 3:00 PM to 7:00 PM

Wednesday, 26 September 2018
3:00-6:00 pm  Educational Session
6:00-7:00 pm  Networking Reception
Arbor Pharmaceuticals, LLC
Five Concourse Parkway, Lobby Level
Atlanta, GA 30328

 

The new European medical device regulations (MDR) and in vitro diagnostic regulations (IVDR) came into force May 2017, with full implementation deadlines now set for May 2020 and May 2022, respectively. The MDR will replace the EU’s current Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC).

Come join regulatory professionals from your area for a combination of educational programming and explore these changes and discuss what it means for manufacturers, regulatory professionals and how you will comply in this ever-changing environment.

This presentation will cover the major changes in the regulatory framework and ways in which device manufacturers are developing plans to meet these changes and to determine the impact on their business.

Immediately following this presentation, we will have a networking reception at the Westin Atlanta Perimeter North Hotel lounge, located directly next door to the meeting facility.

This RAPS Atlanta chapter program is sponsored and hosted by Arbor Pharmaceuticals, LLC and is intended to facilitate networking among area regulatory personnel. Light refreshments will be provided during the educational portion of the event, with heavy hors d’oeuvres and non-alcoholic drinks available at the networking reception. RAC holders may claim three RAC recertification credits.


Featured speaker:
Royth v. Hahn, MS, senior vice president, TÜV SÜD Medical & Health Services


Prior to 19 September:
RAPS Members:  $25
Nonmembers:  $40

On or after 19 September:
RAPS Members: $40
Nonmembers: $55


#AtlantaChapter

Location

5 Concourse Pkwy Lbby Level
Atlanta, GA 30328-5350