What is the EUDAMED Updates?
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.
- Richard Houlihan LinkedIn: https://www.linkedin.com/in/richard-houlihan/
- EUDAMED.Com website: https://eudamed.com/
- EUDAMED database link: https://ec.europa.eu/tools/eudamed/#/screen/home
- EUDAMED registration page: https://webgate.ec.europa.eu/eudamed/landing-page#/
- EUDAMED and Germany: https://www.bfarm.de/EN/Medical-devices/Overview/Europe-and-EUDAMED/_node.html
- EMDN Code Website: https://webgate.ec.europa.eu/dyna2/emdn/ Meeting Minute EUDAMED timeline: https://ec.europa.eu/transparency/expert-groups-register/screen/meetings/consult?lang=en&meetingId=48063&fromExpertGroups=3565
- Playground: https://webgate.training.ec.europa.eu/eudamed-play