Linda Horton says changes won't affect U.S. companies much. Although changes to the European Union's Medical Devices Directives probably won't involve a major overhaul of the regulations or the system ...

DONGGUAN, GUANGDONG, CHINA, January 22, 2026 /EINPresswire.com/ — As global healthcare systems increasingly emphasize ...

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 ...

As is already the case under the current EU Medical Device Directive 93/42/EEC (as amended by Directive 2007/47/EC – “MDD”), the purpose for which the software is intended to be used is and remains ...

Stereotaxis Inc. recently received CE mark recertification for all its devices currently available in Europe under the new Medical Device Regulation (MDR) regulatory framework. The MDR has replaced ...

The European Union’s Medical Device Regulation (MDR) is a complex regulatory framework created to put in place rules and requirements in how medical devices are designed, manufactured, and marketed.

Medical devices with valid certifications under the Medical Device Directive (MDD) will have to prepare to adapt to the incoming Medical Devices Regulation (MDR), particularly for up-classified ...

This Medical Device Directive training will discuss the recently implemented and currently planned changes to the Medical Device Directives across the EU. It includes specific insight from direct ...