On October 30th, 2019, the European Commission announced that the EUDAMED launch is delayed to May 2022. The new timeline combines the EUDAMED launch for medical devices and in-vitro medical devices. The date of application of the MDR remains May 2020.
We are currently working with MedTech Europe and other organizations to understand the full legal impact of the European Commission’s announcement. In the meantime, we want to offer some information on potential impacts on your organization:
- EUDAMED Testing: The European Commission confirmed that UDI registration module tests planned for the end of this year are still on; Playground 2 has been open since November 5, which also includes some test scenarios originally planned for late November. At the MDCG meeting held on November 11, the European Commission confirmed they expect the device registration module to be finalized by March 2020. Therefore, Playground 3, which is https://www.atrify.com/en/eudamed-news/successful-testing-eudamed/going to include all device registration use cases, should be expected before the end of Q1 2020. Regardless of potential changes in the timeline, with atrify, you will have the possibility to take part in all future EUDAMED testings – you should participate in the last tests to fully prepare yourself for EUDAMED.
- Vigilance reports: atrify plans to test M2M upload into EUDAMED for vigilance reports (e.g. MIR). This will enable manufacturers to only manage one automated access point for EUDAMED. The timeline is based on the European Commission’s EUDAMED finish-date, currently planned for October 2020.
- Trading partners: An increasing number of hospitals and GPOs are already asking for MDR compliant data from manufacturers in their RFPs. atrify is going to support those requests by enriching our standard GDSN validations with EUDAMED validations. Customers are going to be able to publish EUDAMED compliant product content to all of their trading partners in 2020 already with the confirmation that the data have been successfully tested versus EUDAMED rules.
- Required MDR Documents: Manufacturers will be obliged to share some new MDR compliant documents (e.g. the Manufacturer Incident Report) with competent authorities until 2022 even without access to EUDAMED’s document upload function; additionally, they are going to have to keep registering devices in national databases. In order to support our customers to meet those regulatory requirements, atrify is investigating, in collaboration with its community, which additional functionalities would be beneficial in terms of product content/document exchange.
atrify and its customers have been the most successful testers during the 1st Playground with thousands of UDIs registered into EUDAMED by October 16, 2019. We remain fully committed to supporting the industry with all UDI regulatory submission requirements, with state of the art solutions made available as early as possible and the active support of our community. As atrify leverages both GDSN and UDI regulatory submissions, we also plan to transform our current MDR Implementation Task Force into a UDI/Regulatory Submission User Group, complementary to our existing Healthcare GDSN User Group.
We will keep you informed about any further developments and their impacts on the EUDAMED roadmap. Do not hesitate to contact us at healthcare@atrify.com for further information.
