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.

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 evolving EU MDR and IVDR present key opportunities for companies to enhance compliance strategies, engage with notified bodies, and optimize market access. Staying informed and proactively ...

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 ...

BUENA, N.J., May 29, 2024 /PRNewswire/ -- COMAR, a leading provider of innovative medical devices and packaging solutions, is thrilled to announce a significant achievement. After rigorous preparation ...

CHALFONT SAINT PETER, England--(BUSINESS WIRE)--A research report from RWS, the world’s leading provider of technology-enabled language, content management and intellectual property services, ...

STORZ & BICKEL GmbH a subsidiary of Canopy Growth Corporation CGC WEED announced the certification of its VOLCANO MEDIC 2 and the MIGHTY+ MEDIC, in accordance with the new EU Medical Device ...