RAPS Atlanta Chapter: Changes Affecting Medical Device Manufacturers—Going From Directive to Regulat

When:  Aug 24, 2017 from 3:00 PM to 7:00 PM (ET)

Come join regulatory professionals from your area for a combination of educational programming, immediately followed by a networking reception at the Westin Atlanta Perimeter North Hotel lounge, located directly next door to the meeting facility.

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).

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.

Join others from your local regulatory community to explore these changes and discuss what it means for manufacturers, regulatory professionals and how you will comply in this ever-changing environment.

This RAPS Atlanta Chapter program is sponsored and hosted by Arbor Pharmaceuticals 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.