atrify GMBH Updates in the Healthcare Industry

First, changes to the EUDAMED deadlines for the UDI and device registration module will allow the industry to benefit from an improved solution when EUDAMED goes live in September 2021. These improvements relate to the originally expected “Minimum Viable Product”, which was planned by the EU Commission at the end of last year. The good news is that the delay in the UDI module gives the EU Commission additional time to further develop critical functionalities of EUDAMED.

Second, on March 31, 2021, the playground for the latest UDI module was opened and the latest technical documentation was shared with the companies participating in the tests - many of these companies are testing with atrify. atrify will continue to provide the Commission with consolidated test feedback from all tests of our customers until the end of April 2021 and will coordinate closely with MedTech Europe and its EUDAMED IT expert working group, of which I am chair.

Companies that cannot take part in the last EUDAMED UDI module playground are encouraged to work with atrify to be part of the next playground, which is planned for the end of July 2021, i.e. before the production start of the EUDAMED UDI module at the end of September 2021 As all manufacturers who have participated in previous tests with atrify and the EU Commission EUDAMED stated, only by participating in the playground tests can you get a complete overview of the information gaps in the device and recognize how complex the EUDAMED Compliance compared to other UDI registrations like GUDID is.

Based on atrify's experience, I strongly recommend:

Maximize your chances of being compliant in a timely manner by not minimizing the prep steps. On average, the device manufacturers we tested lacked more than ½ of the information required to register a device, and this is exactly where atrify can support you today! (Remember - 80% of the time spent on prep work is needed to ensure 20% of the time to run successfully and the verification process)
Work with the right level of outside expertise - Most regulatory compliance initiatives can have a steep learning curve. Because regulatory compliance is critical to the functioning of your business, you should work with a knowledgeable partner who has a solution and a track record that is well-established in the marketplace.

After all, discussions are taking place right now on future UDI regulations in many other countries including Brazil, the UK and Singapore. In addition, we are still working on the implementation of South Korean MFDS connectivity - contact us if you would like to learn more about these and other upcoming requirements.

First, changes in EUDAMED deadlines for UDI & Device registration module will enable the industry to benefit from an improved solution when EUDAMED goes live in September 2021. These improvements are to the originally expected “Minimum Viable Product” planned by the EU Commission at the end of last year. The good news here is the delay of the UDI module provides the EU Commission additional time to more fully develop critical EUDAMED functionalities.

Second, on March 31st, 2021, the newest UDI module playground opened and latest technical documentation was shared with those companies participating in testing - many of these companies are testing with atrify. atrify will continue to provide consolidated testing feedback, from all our client's testing, to the Commission by end of April 2021, and will keep closely aligned with MedTech Europe and its EUDAMED IT Expert working group which I am chairing.

For companies who cannot participate in the latest EUDAMED UDI module playground, you are encouraged to work with atrify to be part of the next playground scheduled for the end of July 2021 which is before the EUDAMED UDI module production go-live at the end of September 2021. Indeed, as indicated by all manufacturers who took place in previous testing with atrify and the EU Commission-EUDAMED, it's only by participating in playground testing that you gain complete visibility