There’s currently a lot of buzz around regulations for digital health, particularly in Europe with the EU Medical Device Regulations (MDR) which went into effect May 26 after a one year delay due to ...
The Central Drugs Standard Control Organisation (CDSCO) has announced risk classification of 119 medical devices pertaining to radiotherapy under the Medical Devices Rules (MDR), 2017, as part of ...
The EU Medical Device Regulation goes into application on 26 May 2020, with the In Vitro Diagnostic Medical Device Regulation set to follow on 26 May 2022. These new Regulations bring sweeping changes ...
“Classification isn’t an administrative detail; it’s the foundation of patient safety,” he says. “If a platform is being used to support clinical decision-making, issue alerts or guide escalation, ...
Complex approval processes and high cost are among the challenges causing US medical device manufacturers to question whether the European Union Medical Device Regulations (EU MDR) are worth the time, ...
Linda Horton says changes won't affect U.S. companies much. Although changes to the European Union's Medical Devices Directives probably won't involve a major overhaul of the regulations or the system ...
The European Commission has published its long-awaited proposal for a regulation amending and simplifying the EU Medical Devices Regulation (EU MDR) and the In Vitro Diagnostic Medical Devices ...
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