If finalized, the changes would reduce the scope of AI regulations for medical devices and include more provisions for rare ...

Since the 2017 publication of the medical device regulation (MDR) and the IVD regulation (IVDR), EU regulations for medical ...

China has imposed reciprocal curbs on imports of medical devices from the European Union, pointing to rising trade tensions between Beijing and Brussels. Companies based in the 27-member bloc are ...

Several stethoscopes lie on a table in a medical clinic. Chinese companies will be excluded from bidding on certain large-scale public contracts for medical devices in the European Union, the bloc's ...

The European Commission (EC) will restrict Chinese companies from EU government purchases of medical devices exceeding €5m ($5.7m). The move comes after a report found that 87% of public procurement ...

Shape’s CE mark under the EU MDR encompasses its Impede and Impede-FX embolisation plugs and Impede RapidFill delivery ...

FILE - President of the European Union Chamber of Commerce in China Jens Eskelund talks during a press conference for the latest report on European companies in China on Thursday, Jan. 9, 2025, in ...

LONDON--(BUSINESS WIRE)--Signifier Medical Technologies Limited (“Signifier”), a global leader in medical technology for sleep-disordered breathing, announces that it has achieved the EU MDR ...

LONDON, Dec 19 (Reuters) - Nicola Osypka's German company has been selling medical devices used in surgery on newborn babies in Europe for decades, but new European Union rules have forced her to make ...

LONDON, June 27 (Reuters) - (This June 27 story has been corrected to say June 27, not July 27, in paragraph 2) Brussels must act to prevent essential medical devices for children from disappearing in ...