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BfArM - Reporting risks - Vigilance System

    https://www.bfarm.de/EN/Medical-devices/Tasks/Risk-assessment-and-research/Reporting-risks/_artikel.html
    In according with the Act on Medical Devices (MPG) and the German Safety Plan for Medical Devices (MPSV), the Federal Institute for Drugs and Medical Devices (BfArM) ensures the central collection, analysis and evaluation of risks arising from the use or …

German Medical Devices Safety Ordinance (Medizinprodukte ...

    https://www.beoberlin.de/german-medical-devices-safety-ordinance-medizinprodukte-sicherheitsverordnung-mpsv/?lang=en
    German Medical Devices Safety Ordinance (Medizinprodukte-Sicherheitsverordnung– MPSV) The German Medical Devices Safety Ordinance (MPSV) regulates the …

Medical Device Safety Action Plan: Protecting Patients, …

    https://www.fda.gov/about-fda/cdrh-reports/medical-device-safety-action-plan-protecting-patients-promoting-public-health
    Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health The FDA’s Center for Devices and Radiological Health (CDRH)'s vision for medical device safety is …

Medical devices: guidance for manufacturers on vigilance

    https://www.gov.uk/government/collections/medical-devices-guidance-for-manufacturers-on-vigilance

    Vigilance relating to medical devices - Swissmedic

      https://www.swissmedic.ch/swissmedic/en/home/medical-devices/reprocessing---maintenance/vigilance-mep.html
      Vigilance Vigilance relating to medical devices According to the Therapeutic Products Act (TPA, SR 812.21), professional users are required to notify Swissmedic of serious …

    BfArM - Medical devices

      https://www.bfarm.de/EN/Medical-devices/_node.html
      Field Corrective Actions include removals of medical devices from the market or any other corrective action on devices in use. In general, the manufacturer implements field …

    Act amending the Regulations governing Medical …

      https://www.bundesgesundheitsministerium.de/fileadmin/Dateien/3_Downloads/Gesetze_und_Verordnungen/GuV/M/MPG_englisch.pdf
      are treated as medical devices in their own right. (2) The present Act shall also apply to the use, operation and maintenance of devices which are not placed on the market as …

    3 5 Of The Ordinance On Medical Devices Vigilance

      https://dayofdifference.org.au/0-9-medical/3-5-of-the-ordinance-on-medical-devices-vigilance.html
      On 19 May 2021, the Federal Council approved supplementary provisions to the implementing regulations on medical devices. These enter into force on 26 May 2021, at …

    Ordinance On Medical Devices Vigilance Mpsv | Day of Difference

      https://dayofdifference.org.au/o-medical/ordinance-on-medical-devices-vigilance-mpsv.html
      The German Ordinance on Medical Devices Vigilance (MPSV) regulates the recording, evaluation and prevention of risks arising from the use or application of medical …

    Ordinance on Medical Devices in German - English …

      https://glosbe.com/en/de/Ordinance%20on%20Medical%20Devices
      The German Ordinance on Medical Devices Vigilance (MPSV) regulates the recording, evaluation and prevention of risks arising from the use or application of medical …



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