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.

The evolving European regulatory landscape presents significant market opportunities in digital medical devices with AI components. By understanding and navigating key regulations like the EU MDR, AI ...

GUILFORD, Conn., Feb. 21, 2023 (GLOBE NEWSWIRE) -- Hyperfine, Inc. (HYPR), the groundbreaking medical device company that created the Swoop ® system, the world's first FDA-cleared portable MRI system, ...

Traditionally, if medical device manufacturers wanted to get products into a major market quick, they obtained CE Marking in the European Union first. The EU required proof of safety and performance, ...

DUBLIN--(BUSINESS WIRE)--The "Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations" conference has been added to ResearchAndMarkets.com's offering. This intensive four-day ...

The "The EU Regulations for Digital Medical Devices with AI Components - A Basket Full of Requirements - What Does a Manufacturer Need to Consider? (Dec 9, 2025)" training has been added to ...