This is another important step on the way to the introduction of EUDAMED and the MDR / IVDR. This means that medical device manufacturers will immediately be able to register their UDIs in the new European regulatory database.
atrify is at the forefront of testing the UDI module with the European Commission, together with our community of leading manufacturers since 2019, whom we would like to thank for their active participation and trust . However, the industry has not yet been able to properly test all the planned functions of EUDAMED because the technical documentation of the Commission was missing or the functions were not available in the previous EUDAMED playground (test) environments; therefore we cannot judge today how stable and usable the production version of the UDI module published on October 4th is. Updated technical specifications are still awaited by the European Commission, and we will carry out further intensive tests in the playground over the next few months to ensure that the industry can itself safely and efficiently start registering UDIs in EUDAMED after thorough user acceptance tests by EUDAMED. Start now to test your various use cases in the playground with atrify in order to be able to register your devices in EUDAMED in good time.
EUDAMED is still very new and highly complex and is based on the basic principle that the data should be completely correct from the start in order to avoid any correction . It is critical that you have a thorough understanding of the requirements of the UDI module in order to be compliant with the regulation. We are here to help you make your trip as smooth and comfortable as possible.
In the last few months atrify has advised numerous manufacturers on their registration with EUDAMED. We also help you to master your EUDAMED Challenge and ensure the compliant, fast and easy transfer of your UDI device data in EUDAMED.
Following the release of the Actor module live since December 2020, the UDI and CERTIFICATE modules went to production in EUDAMED on Monday 4th October.
This is another critical step towards the roll-out of EUDAMED and the MDR / IVDR; which means that manufacturers of medical devices will now be able to register their UDIs in the new European regulatory database.
atrify has been at the forefront of testing with the European Commission the UDI module, together with our community of leading manufacturers since 2019 and whom we want to warmly thank for their active involvement and trust. However, the Industry has not yet been able to properly test all planned functionalities of EUDAMED due to missing technical documentation from the Commission / functionalities not available in previous Playground (test) environments of EUDAMED; therefore we cannot assess today, how stable and usable is the production version of the UDI module released on 4th October. Updated technical specifications are still due by the European Commission and we will continue intensely testing in the Playground over the next couple of months to ensure the industry can safely and efficiently start registering UDIs in EUDAMED after thorough User Acceptance Testing of EUDAMED itself. Start testing your various use cases within the Playground with atrify now to be ready with registering your devices in EUDAMED on time.
EUDAMED is still very new and is highly complex, and is built on the key principle that data should be fully correct from the beginning to avoid any correction. It is essential that you have a full understanding of the requirements of the UDI module to be compliant with the regulation. We are here to support you to make it a journey as smooth and comfortable as possible.
During the last fe
