EU-MDR Soft Transition - Webinar Recording/Transcript
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.