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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 …
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 …
EU Medical Device Vigilance Reporting in Europe - Emergo
- https://www.emergobyul.com/services/medical-device-vigilance-and-incident-reporting-europe
- The vigilance requirements in the Medical Device Regulation (MDR) No. 2017/745 (for medical devices or active implantable medical devices) and the In Vitro Diagnostic …
An Overview of Medical Device Law in Germany - md …
- https://www.md-institute.com/en/reprocessingmedical-devices.html?file=files/cto_layout/press-releases/medical-technology/processing-medical-devices/An-Overview-of-Medical-Device-Law-in-Germany.pdf
- The implementation of the European requirements is governed in Germany by the Medical Device Act, the Ordinance on Medical Devices (Verordnung über Medizinprodukte, …
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 Devices Information System - DIMDI
- https://www.dimdi.de/dynamic/en/medical-devices/information-system/
- MEDICAL DEVICES INFORMATION SYSTEM Access for manufacturers, sponsors, authorised representatives and competent authorities. Please note that the entire …
New regulations applicable to medical devices as of 26 …
- https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/neue-regulierug-mep-26-05-2021.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 …
Vigilance relating to medical devices - Swissmedic
- https://www.swissmedic.ch/swissmedic/en/home/medical-devices/reprocessing---maintenance/vigilance-mep.html
- Vigilance relating to medical devices. According to the Therapeutic Products Act (TPA, SR 812.21), professional users are required to notify Swissmedic of serious incidents …
Ordinance on medical devices vigilance - German …
- https://www.linguee.com/english-german/translation/ordinance+on+medical+devices+vigilance.html
- Many translated example sentences containing "Ordinance on medical devices vigilance" – German-English dictionary and search engine for German translations. Ordinance on …
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