EUDAMED UDI module live

Following the release of the Actor module, which has been live since December 2020, the UDI and CERTIFICATE modules is live in production since Monday 4 October - EUDAMED is currently undergoing a "major upgrade" and should not be used before this date. (See EU Commission communication on website,https://ec.europa.eu/tools/eudamed/#/screen/home)

This is another important step towards the implementation of EUDAMED and the MDR/IVDR; it means that medical device manufacturers cannowregister their UDIs in the new European Regulatory Database.

atrify has been at the forefront of testing the UDI module with the European Commission since 2019 - together with our community of leading manufacturers, whom wewould like to sincerely thank for their active participation and trust. However, industry has not yet been able to properly test all of EUDAMED's planned features due to the lack of technical documentation from the Commission or the unavailability of features in EUDAMED's previous playground (test) environments; therefore, we are not yet able to assess today how stable and usable the production version of the UDI Module available on 5 October will be. Updated technical specifications are still awaited from the European Commission. Atrify will beconducting further intensive testing in the Playground over the next few monthsto ensure that, after thorough user acceptance testing of EUDAMED itself, the industry can safely and efficiently start registering UDIs in EUDAMED. Start testing your different use cases within the Playground with atrify now to complete the registration of your medical devices in EUDAMED in time.

EUDAMED is still very new and highly complex and is based on the basic principle thatdata should be completely correct from the beginning to avoid any correction. It is crucial that you know exactly what the UDI module requires in order to comply with the regulation. We are here to support you to make the journey as smooth and comfortable as possible.

In recent months, atrify has advised numerous manufacturers on their registration with EUDAMED. We can also help you master your EUDAMED Challenge and ensure the compliant, fast and easy transfer of your UDI device data into EUDAMED.

Following the release of the Actor module live since December 2020, the UDI and CERTIFICATE modules should go to production in EUDAMED on Tuesday 5th October – EUDAMED is currently going through a “major upgrade” and should not be used before this date. (See the communication from the EU Commission on their website,https://ec.europa.eu/tools/eudamed/#/screen/home)This is another critical step towards the roll-out of EUDAMED and the MDR/IVDR; which means that manufacturers of medical devices willnowbe 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 whomwe 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 the Production version of the UDI module available on 5th October will be. Updated technical specifications are still due by the European Commission andwe will continue intensely testing in the Playground over the next couple of monthsto 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 thatdata 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 few months atrify has been advising numerous manufacturers with their registration at EUDAMED. We can also help you to master your EUDAMED challenge and to ensure the compliant, fast and simple transfer of your UDI device data into EUDAMED.

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