EUDAMED Update: Should you register your medical devices now?
Recently EUDAMED made a major Update which was the release of the Device registration module. This is something that all Medical Device manufacturers need to listen to as this may impact their workload.
Richard Houlihan from Eudamed.com accepted to come and tell us more about this update and provide you also with some advice on how to manage it.
So we will talk:
- EUDAMED progress
- EUDAMED Device registration module
- Should you register now or later
- Should you do it manually or use a service provider
Richard Houlihan is also providing training to your team on how to implement EUDAMED so don’t miss it. The links are below.
Who is Richard Houlihan?
Richard Houlihan has been in IT-related businesses for 25+ years. He holds a BSc in Computing and an MBA in 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 companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com 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, podcasts, Online courses…
Links
- Richard Houlihan Linkedin Profile: https://www.linkedin.com/in/richard-houlihan/
- Eudamed.com website: https://eudamed.com/
Training sessions
- Training: 26th & 27th October https://eudamed.com/index.php/product/live-online-eudamed-training-26th-27th-october-2021/
- Training: 23rd & 24th November https://eudamed.com/index.php/product/live-online-eudamed-training-23rd-24th-november-2021/
For the manufacturers, without too many UDI DI’s an offer that includes our templates.
- Up to 100 UDI DI’s https://eudamed.com/index.php/product/eudamed-saas-100/
- Up to 300 UDI DI’s https://eudamed.com/index.php/product/eudamed-saas-300-udidi/
4 Replies to “EUDAMED Update: Should you register your medical devices now?”
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Hi!
Thank you for all the information you are putting online for us newbies to learn from. It’s great!!
I just followed this episode to get to know more about Eudamed and how we from the customers side can harvest information from it. I am employed in Central Norway Regional Health Authority who runs the hospitals in middle region of Norway. I’m currently working on mapping out wich of the products in use are MDR class 3 and enrich our database with necessarry data, like UDI-DI and PI, MDR klassification and manufactorer and manufactorers catalogue number/product number. Until now, I have been using accessGUDID (FDA’s database) to find info, but some of the products have different GTINs or are not in FDAs database at all. So my hope is that I can easily harvest data from EUDAMED – searching by manufaturers catalouge number and get the info I need. Is this possible for products that are allready registered? The best for me would be to download a spreedsheat (per manufacturer) with product name, cat.number, GTINs, MDR class and classifications (like GMDN). But this is maybe far to optimistic to hope for for a long time yet??
Kind regards
Anita Duun Lorentsen
Hi Anita, I am sure this is possible but don‘t know the process as I am not a software developer. But I can search for it.
very informative podcast. thanks
Hello,
Thank you Monir and Richard for a very informative podcast!
Deborah