Regulation (EU) 2017/745 (MDR)

22 de jul. de 2024 · 6m 57s
Regulation (EU) 2017/745 (MDR)
Descripción

Welcome to the new Di Renzo Regulatory Affairs podcast!In the ever-evolving landscape of medical device regulation, it is crucial to stay up-to-date. That's why today we'll delve into Regulation (EU)...

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Welcome to the new Di Renzo Regulatory Affairs podcast!In the ever-evolving landscape of medical device regulation, it is crucial to stay up-to-date. That's why today we'll delve into Regulation (EU) 2023/607, a significant amendment to Regulation (EU) 2017/745 (MDR) that introduces an extension of the transition period and defines the criteria for benefiting from it.As Regulatory Affairs experts dedicated to Class I medical devices, Di Renzo Regulatory Affairs is ready to support manufacturers in this delicate transition process.In this podcast, we will guide you through the details of Regulation 2023/607, clarifying:
  • Which Class I medical devices are eligible for the extension
  • How to correctly assess the classification of your device
  • What are the specific timelines for the extension
  • How to make the most of this additional period to prepare for the MDR
By listening to this podcast, you will gain the knowledge you need to confidently navigate the new regulations and plan a smooth and efficient transition to the MDR.Stay tuned to discover how Di Renzo Regulatory Affairs can support your success in the new medical device regulatory framework!Here are some additional points that you may want to include in your podcast intro:
  • Introduce Di Renzo Regulatory Affairs and its expertise in medical device regulation.
  • Highlight the importance of the MDR and its impact on Class I medical device manufacturers.
  • Emphasize the value of Di Renzo Regulatory Affairs' services in helping manufacturers comply with the MDR.
  • Encourage listeners to subscribe to the podcast and leave reviews.
I hope this is helpful!
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