BAD HERSFELD, GERMANY, March 9, 2026 / EINPresswire.com / — p36 GmbH today announced the successful completion of UDI Hub’s development. UDI Hub is now generally available, and the first ...
The first module of the European database on medical devices, EUDAMED, also referred to as the Actor registration module, will be made available to EU Member States and economic operators on 1 ...
New solutions deliver enterprise-grade data access and streamlined EUDAMED compliance, driving smarter, faster decisions across the business PITTSBURGH, April 29, 2025--(BUSINESS WIRE)--Rimsys, the ...
The official compliance date for the European Union’s Medical Device Regulation (MDR) is now officially in force after a delay of two years. One of a number of unfortunate side effects is that the ...
The EU’s Medical Device Coordination Group (MDCG) on Monday released two new documents explaining how legacy devices can be registered in Eudamed without a unique device identifier (UDI) and how ...
The EC's European Database on Medical Devices (EUDAMED) is conceived as a way of improving transparency and oversight of medical devices and in vitro diagnostics (IVDs) on the European market. Image ...
On 15 February 2021, the European Commission published guidance on the Management of legacy devices in EUDAMED. This guidance addresses the registration and identification of legacy devices in EUDAMED ...
The European Commission's (EC) Medical Device Coordination Group (MDCG) has provided a set of templates to fulfill European Medical Device Regulation (MDR) requirements on submitting clinical ...
On 26 May 2022, the European Commission will roll-out the new in-vitro diagnostic regulation. One of the main changes in the IVDR is to increase the involvement of NBs. Under the current IVDD, less ...
New solutions deliver enterprise-grade data access and streamlined EUDAMED compliance, driving smarter, faster decisions across the business Rimsys, the global leader in Regulatory Information ...