EUDAMED is delayed, so What? with Richard Houlihan


In this 50th episode of the Podcast, we will talk about the announcement that was made this November 2019 by the European Commission of the EUDAMED Delay.

Richard Houlihan, CEO of EUDAMED.EU is my guest and will help us understand the situation and what should be done.

If you remember, Richard was on episode 25 of the podcast.
All that Richard shared on this episode is still relevant. So don’t hesitate to listen back to it.

One conclusion of this episode is the fact that EUDAMED is delayed but MDR 2017/745 is not so you should continue your transition.

Who is Richard Houlihan?

Richard Houlihan has been in IT-related businesses for 25+ years. He holds a BSc in Computing and an MBA Information management. The varying IT roles have led to him living in several countries, working across 6 blue chips, 3 start-ups and 3 different directorates within the European Commission.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

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2 Replies to “EUDAMED is delayed, so What? with Richard Houlihan”

  1. Montserrat Gutiérrez de Dios

    Hi Monir,
    Thanks very much you both for so clear and easy understanding explanation.
    I have a question that I would like you to clarify, if possible.
    Company class I product reclassification IIa under MDR. We are now upgrading the QMS to have CE Certificate MDR before end transition period May 26, 2020.
    Will we have to upload all the data to the Eudamed of the period May 27, 2020 – Eudamed go live??
    Thanks very much for all your help.

    • Monir El Azzouzi

      Hi Montse,
      As EUDAMED will be delayed, this means that all the data that should have been uploaded from May 26th 2020 should now be kept until EUDAMED is live and then uploaded all at once.
      So you will need to keep your data on a safe place (Controlled document)
      But this is not required for MDD products. So before your product is MDR, you should follow the normal route, but as soon as your product is MDR compliant, then you need to get these data saved.

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