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 ...

The 2007 directive expands the existing definition of a medical device to cover "any instrument, apparatus, appliance, software, material, or other article, whether used alone or in combination, ...

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 ...

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

LAUSANNE, Switzerland--(BUSINESS WIRE)--Neo Medical SA (Neo), a Swiss technology company specializing in spine surgery, today announced the approval of its entire product portfolio under the European ...

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 ...