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 ...

CARLSBAD, Calif., Dec. 06, 2022 (GLOBE NEWSWIRE) -- Acutus Medical, Inc. (“Acutus” or “the Company”) (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias ...

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.

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 ...

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 ...

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, ...

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

The European Commissioner for Health and Food Safety, Stella Kyriakides, has proposed measures to extend the transition rules of Medical Device Regulation (EU) 2017/745 (MDR) at the Employment, Social ...

Neo Medical SA received certification under the EU Medical Device Regulation for its entire portfolio of spine surgical technologies. The approval means that the company can continue selling its ...

Adhesives specialist Avery Dennison Medical has upgraded its SilFoam Lite wound dressing, which now comes with certification to the European Union’s Medical Devices Regulation (MDR) as well as ...