Healthcare manufacturers will have 1 more chance to participate in the EUDAMED playground for UDI & Device registration module which will be opened by the European Commission at the end of July and run during the month of August, enabling direct interaction with the European Commission support team during this period. After this, the EUDAMED IT team will implement final bug fixes, and the UDI module will go live at the end of September 2021, while the IT team moves its focus to delivering the 3
Healthcare manufacturers will have 1 more chance to participate in the EUDAMED playground for UDI & Device registration module which will be opened by the European Commission at the end of July and run during the month of August, enabling direct interaction with the European Commission support team during this period. After this, the EUDAMED IT team will implement final bug fixes, and the UDI module will go live at the end of September 2021 , while the IT team moves its focus to delivering the 3 remaining EUDAMED modules - including the critical vigilance one.
If you have any question regarding your understanding of the EUDAMED requirements (which are particularly complex compared to other UDI regulations such as GUDID) and the EU Commission regulatory expectations, this is the time to get ready and test your various use cases (regulated products, systems & procedure packs, legacy devices, depending on your risk classes and product types etc.) and get real-time feedback from EUDAMED, as a final preparation for the UDI module being live in Production. Especially considering that EUDAMED is really not designed to enable simple corrections of data once submitted - you must really make sure your product information is fully correct before registering your devices.
Register for our free online sessions to get more information and address your questions to our experts:
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Leveraging its long experience of working with EUDAMED, the European Commission and the Industry, atrify offer you a unique opportunity to support you during this summer playground and make it as easy as possible to go through.
Regardless of what you have already scheduled for this summer to relax from the Covid 19 crisis and enjoy the removal of many restrictions, we warmly recommend you allocate some time to this critical Playground testing, and we will definitely be at your side during this period!
Manufacturers in the medical industry have another chance to participate in the EUDAMED-Playground for the UDI and device registration module , which will be opened by the European Commission at the end of July and will take place in August. During this period, direct interaction with the European Commission's support team will be possible. The EUDAMED IT team will then implement the final error corrections, and the UDI module will go live at the end of September 2021. At the same time, the IT team is concentrating on the provision of the three remaining EUDAMED modules - including the critical vigilance module.
If you have any questions regarding EUDAMED requirements (which are particularly complex compared to other UDI regulations like GUDID) and the EU Commission's regulatory requirements, now is the time to prepare for them and test your various use cases (regulated products, systems & procedure packs, legacy devices, depending on your risk classes and product types, etc.) and receive real-time feedback from EUDAMED as the final preparation for the UDI module that goes into production. Especially considering the fact that EUDAMED is not designed to be simple
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