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
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
The European Commission appointed DEKRA Certifiation GmbH as the IVDR notified body. This is an addition to the previously appointed MDR notified bodies: BSI UK, TÜV Süd, DEKRA DE, IMQ Italy and TÜV Rheinland. The commission is expecting to end up with twelve to fifteen notified bodies by the end of this year. For more information: https://ec.europa.eu/growth/tools-databases/nando/
For our next GDSN Healthcare User Group we are excited to have two contributions from our partners: GS1 Denmark is going to present their GDSN project with Danish hospitals and Virtual Stock, a catalogue service provider, is going to explain how to leverage the GDSN to make manufacturers’ product data available to trusted systems.The next GDSN Healthcare User Group Call is scheduled for October 24, 2019 – if you with to join the GDSN Healthcare User Group, contact us at email@example.com.
During latest meeting of Member States with EU Commission (MDCG meeting held on 30th September), the following deadlines have been confirmed: May 2020: for Date of Application (release of EUDAMED in Production : March 2020) November 2020: first launch of most important vigilance module functionalities (expected to include first M2M key reports) May 2022: all EUDAMED modules fully functional (including a full Vigilance module completed).
Last week, atrify completed successful testing with EUDAMED; uploading UDI data and receiving the positive acknowledgement message 'success' from EUDAMED as part of the DTX testing process run by the European Commission. The testing will be open until 14th October, so we have one more week to run, in order to test additional use cases from our participating customers. Thanks for the community to make it work and looking forward to EUDAMED going to Production early 2020!
Our know-how for the healthcare sector
Suppliers and retailers in the healthcare community have good reasons for relying on atrify: