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Since the MDR allows warnings or precautions to be taken that need to be brought to the immediate attention of the user of the device, and to any other person to be kept to a minimum on the label, I would recommend applying the symbols from ISO 15223-1:2016 'Consult instructions for use' This Indicates ...

Hello,  There is MEDDEV 2. 4/1 Rev. 9 on Classification of medical devices and MEDDEV 2.1/6 on Standalone software… Best regards, Stefan ------------------------------ Dr. Stefan Menzl Geschäftsführer / Executive Director Qserve Group Deutschland GmbH +49 152 900 28156 stefan.menzl@qservegroup.com ...

As already mentioned, the new EUDAMED will become the EU database which will contain information about  - type of devices on the EU market (UDI-DI) - Economic Operators (manufacturer, EU representative, importer) - Certificates - Vigilance reporting - Application to initiate clinical trials - Market ...

Hi Meenakshi, Compassionate use is not specifically addressed in the German law on medical devices (MPG). It is only possible based on constitutionally guaranteed freedom to perform diagnosis and therapy for medical doctors. Medical doctors at the same time have an obligation to treat patients. ...