EU-MDR Soft Transition - Webinar Recording/Transcript

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EU-MDR Soft Transition

If you plan to continue putting devices on the European market, you’ll need to implement the EU-MDR. 

Due to the slow progress in the EU resources — guidance documents, harmonized standards and notified bodies — companies are being sent to the soft transition.

Dan O’Leary, one of FDAnews’s most popular presenters, will explain the hybrid system where you maintain a device certificate under the MDD and a QMS under the MDR. After 90 minutes you’ll understand:

  • the dates from the EU-MDR for when the hybrid system can apply
  • the requirements for working with the MDD Notified Body
  • the requirements from the MDD that apply to the device
  • the three elements from the MDR Chapter VII – post-market surveillance, market surveillance, and vigilance
  • the role of economic operators and their registration requirements
  • the role of device registration and the required data elements
  • how to structure the technical documentation for the hybrid system

BONUS: You’ll receive a set of checklists to help implement the hybrid system required during the soft transition period.

Start implementing the hybrid MDD/MDR system to keep your products on the European market until the full EU-MDR comes into effect.

All members of the EU-MDR transition project should attend, to include:

  • Quality Directors
  • Quality Managers
  • Regulatory Affairs Directors
  • Regulatory Affairs Managers
  • Design Engineering Managers
  • Product Marketing
  • Post-production Specialists
  • Vigilance Specialists

Dan O’Leary is President of Ombu Enterprises LLC, a company offering training and execution in Operational Excellence focusing on analytic skills and a systems approach to operations management. Mr. O’Leary has 30+ years’ experience in quality, operations, and program management in regulated industries including medical devices and clinical labs. He is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.