The atrify healthcare solution
Serving more than 1,500 organizations around the globe, managing more than 1 million products in the healthcare sector alone, atrify is one of the leading experts for product content solutions in the healthcare industry.
National Health Services (NHS)
Future Unique Device Identification (UDI) Databases
Food & Drug Administration (FDA) GUDID
Our healthcare solution is specifically designed to manage and publish Unique Device Identification (UDI) data to healthcare authorities (such as EUDAMED, FDA GUDID) and all necessary commercial data to commercial partners (such as hospitals, clinics, NHS, and group purchasing organizations) worldwide. It allows medical device manufacturers to distribute validated and authentic UDI and commercial data in compliance with different regional requirements. As future UDI regulations develop and more projects regarding product data exchange mature, atrify will continue to expand our healthcare solution to fit manufacturers’ regulatory and commercial needs.
Healthcare & EUDAMED News
Following the public announcement by the European Commission of the postponement of EUDAMED’s launch until May 2022, the CAMD Executive group has prepared an open letter to share its concerns about this development. The CAMD Executive group emphasises the need for the application of the new Regulation and on the continued significant commitment needed by all stakeholders to this. Please have a look at the following Link for further information: https://www.camd-europe.eu/regulatory/eudamed-state-of-play-open-letter-from-the-camd-executive-group/
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...
Today the European Commission announced that the MDR 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. We’re going to share more information about potential impacts on your organization and how atrify plans on enabling its customers to be prepared for the approaching MDR application in May 2020. Stay tuned.
The EUDAMED M2M UDI testing, organized by the European Commission, ended today. With 1156 UDIs successful uploads, we are proud to confirm that we are the most successful connector participating. A big thank you to our customers who have been working with us and to our team – together we are able to achieve a very positive outcome. If you want to get ready for the next EUDAMED testings, contact us at email@example.com
We are happy to have a booth again this year at the Healthcare live! in Kiel on 22-23 October. Visit us! If you are not registered yet, you can find all information here: https://healthcare-live.de
Our know-how for the healthcare sector
Suppliers and retailers in the healthcare community have good reasons for relying on atrify: