What is the EUDAMED Updates?

Richard Houlihan – Eudamed.com What is the EUDAMED Update? monir el azouzzi easy medical device

EUDAMED is the European Database for Medical Devices. In this episode, Richard Houlihan will be my guest and will explain to us the situation regarding EUDAMED. For the moment this database is not finished, so should you use it? We will also review the timeline and help you understand what you should do now. Don’t miss that episode as EU MDR 2017/745 and IVDR 2017/746 ask you to register your company, your products in this database.

Who is Richard Houlihan?

Richard Houlihan is an international speaker and guest university lecturer on EUDAMED. His time running the European Commission IT teams developing EUDAMED has given him unrivalled insights into how EUDAMED affects the MedTech industry. This EUDAMED experience and his 28 years in IT give him a real advantage when helping companies prepare for EUDAMED, FDA GUDID, and other regulatory submissions.   His company EirMed with the website eudamed.com provides EUDAMED regulatory submission software solutions to help Manufacturers large and small including full project management, training, an EUDAMED mobile search app, and support to help Manufacturers, Importers, European authorised reps, and Distributors meet their EUDAMED obligations. To date, Richard and his team have trained over a thousand people on EUDAMED and helped hundreds of companies with EUDAMED consultancy and their regulatory data submissions to EUDAMED.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

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Richard Houlihan – Eudamed.com What is the EUDAMED Update? monir el azouzzi easy medical device

One Reply to “What is the EUDAMED Updates?”

  1. Surya Prakash

    It was a very nice session on UDI, and we learned a lot of things about it. Actually, one of my concerns is that we are uploading our legecy device to EUDAMED. By mistake, we selected the option “No Longer Placed on the EU Market,” but that device bears the CE mark and will be sold on the EU market in the near future.
    We want to edit this by creating a new version to rectify this issue, but it has not happened.
    Kindly help on how to rectify this issue?
    does only one option to delete the existing UDI details and upload again with the correct details or something else.?

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