EUDAMED Test 2019 successfully passed

16 Dec 2019

atrify has tested thousands of devices with 8 participating manufacturers in the first rounds of the EUDAMED tests (Playground 1 & 2).

The EUDAMED UDI Playground has been available for three months to enable data exchange via machine-to-machine and third-party providers. Therefore, we now have a good base of knowledge and experience and we are happy to share our results with the healthcare industry.

Prior to the start of testing on September 16, atrify prepared the implementation of EUDAMED messages and the establishment of connectivity via AS4. In the first four weeks of Playground 1, atrify then officially tested the connectivity and received UDI test data for around 4,500 devices from 8 participating manufacturers in the healthcare industry. These files were mapped and converted into around 1,500 EUDAMED XML messages and 82% were successfully sent to EUDAMED. The GROW team of the EU Commission supported atrify in clarifying questions and finding solutions and named atrify as "Champion" in a public webinar.



Which test scenarios were successfully tested?

  • Playground 1 (until the end of October) enabled the registration of a new MDR-DEVICE, i.e. new basic UDIs together with new UDI-DIs.
  • These included all basic UDIand UDI-DI data, including the DI package level.
  • Since Playground 2 (November), it has been possible to send new UDI_DIs that refer to an existing basic UDI.
  • atrify has also successfully tested the registration of a new MDR device as a system or treatment unit.

What were the lessons learned during the test?

  • The connection to EUDAMED via AS4 requires time and good preparation. Using an experienced and recognized third-party provider such as atrify makes it easy and cost-effective for the manufacturer, as they do not have to implement AS4 themselves (especially connectivity work, which is carried out and maintained by atrify for all their customers).
  • The response messages from EUDAMED are still being processed. Some of the messages are not directly linked to IDs or to the submitted business rules and some have cryptic descriptions.
  • In particular, the understanding of the certification rules must be further deepened in the next round of tests.

What test scope will be part of the next Playground 3?

Due to the gradual implementation of EUDAMED, the following parts could not yet be tested in 2019, but will be tested at the beginning of 2020:

  • Updating and versioning existing basic UDIs or UDI DIs
  • Registration of legacy devices (i.e. MDD, IVDD or AIMDD related products)
  • Some more complex validation rules that were not yet implemented in the previous playgrounds.

Deadlines for Playground 3

The official deadlines for Playground 3 have not yet been confirmed by the European Commission, but as the new Data Dictionary was published at the beginning of December and the UDI & Device Registration module is expected to be completed by March 2020, it can be assumed that testing in Playground 3 will take place in the first quarter of 2020. This may be the last opportunity for manufacturers to test directly with EUDAMED and receive support from the EU Commission team before the EUDAMED go-live date. Therefore, it is important that you participate in this testing round to be prepared before going live.

We are here for you: Our atrify experts for EUDAMED

The Professional Services experts at atrify will be happy to help you with the EUDAMED tests. They will first conduct a detailed attribute analysis with you to ensure that you have the complete product data sets required to successfully register your product with EUDAMED. This is an important requirement as, in our experience, 25 to 50% of data is not available in companies' systems today. During the EUDAMED test, we support you in sending data to the EUDAMED Playground via the atrify Access Point - all you need to do is provide us with data in an Excel template and we will transform the EUDAMED XML message for you. We will also provide you with the response messages received from EUDAMED and analyze them. Together we will ensure a smooth transition to EUDAMED. This will also help you to ensure that your data is MDR compliant before May 2020, so that you are ready to share it with trading partners and register your devices in EUDAMED as soon as the UDI & Device Registration module goes live.

Maik Sippl

Maik Sippl

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