The "A Regulatory Update on the Medical Device and In-Vitro Diagnostic Regulations in the EU (European Union) and UK Training Course (Apr 29, 2026)" training has been added to ResearchAndMarkets.com's ...

We previously reported on the FDA’s laboratory-developed test (LDT) rule published on May 6, 2024, which classifies LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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 removal of the “sell-off” periods (MDR and IVDR). As becomes apparent from the above, the changes to the transition periods are limited to the MDR. The transitional regime of the IVDR was extended ...

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 ...

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, ...

Prioritizing compliance with European Union Medical Device Regulations (EU MDR), especially for legacy products, can be daunting, despite the extension of EU MDR deadlines from 2026 to 2028. To ...