EU MDR and IVDR Webinar: Prepare for your Transition

Background

Both the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR) were published in the EU Official Journal on May 5, 2017, and formally came into force on May 25, 2017. Medical device manufacturers have a three-year transition period for MDR while IVDR has a five-year transition period.

The new regulations objective is to ensure EU legislations are on par with medical advances, to protect the safety of the community and the patient.

This webinar aims to help increase your knowledge of the new MDR and IVDR regulations.

In the webinar session, the following topics will be discussed:

• MDR and IVDR: introduction and general information
• SGS: designation of scope and timelines for MDR and IVDR
• Transition timelines: cut-off dates for directives
• Transition modalities
  • What we need to know
  • What we need to define together
  • When we should start
• How SGS can help

Presenters

Sharon Williams - Global IVDR Product Manager

Sharon is the SGS IVD Certification Manager, and Global IVDR Product Manager. She has worked for Notified Bodies in the field of In Vitro Diagnostic Devices for almost 20 years. She is also an active member of the TeamNB for IVD.

Virginie Siloret - Global MDR Product Manager

Virginie is the Global MDR Product manager, working for SGS for almost two years, with over 15 years of experience in the medical devices industry.

Target Audience

This webinar is intended for, but not limited to, regulatory personnel, managers, CEOs, CFOs, MD/IVD device industry employees and MD/IVD device users who want to learn about the new regulations.

Language: English
Cost: No charge

For more information, please contact:

Anna Amato
Senior Global Marketing Manager
t: +1 201 508 3000