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 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.
DONGGUAN, GUANGDONG, CHINA, January 13, 2026 /EINPresswire.com/ -- As healthcare increasingly shifts towards at-home ...
On July 28, the U.S. Food and Drug Administration (FDA) issued the final guidance “Multiple Function Device Products: Policy and Considerations,” which describes FDA's regulatory approach and policy ...
Dublin, Nov. 05, 2025 (GLOBE NEWSWIRE) -- The "EU MDR and IVDR: Key Updates and Compliance Strategies for 2025 (Aug 6, 2025)" training has been added to ResearchAndMarkets.com's offering. The EU ...
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 ...
The UK government recently announced an indefinite extension to the use of CE marking for most goods. The extended recognition of CE marking does not, however, apply to medical devices. That said, the ...
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