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Home » Store » Webinar Recordings » EU-MDR Soft Transition - Webinar Recording/Transcript

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EU-MDR Soft Transition - Webinar Recording/Transcript

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Product Details

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.

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