German Medical Device Safety

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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 corrective actions by sending an advisory notice to inform operators and users about risks of …

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) …

Medical Device Regulations in Germany

https://www.regdesk.co/reg-ger/

Since Germany is a European Union member country, it follows the device classification system that of EU Medical Device …

Medical Devices - DIMDI

https://www.dimdi.de/dynamic/en/medical-devices/

Medical Devices Medical Devices Important notice As part of the merger of DIMDI with BfArM, contents of this website have been moved to the website www.bfarm.de. …

Act amending the Regulations governing Medical …

https://www.bundesgesundheitsministerium.de/fileadmin/Dateien/3_Downloads/Gesetze_und_Verordnungen/GuV/M/MPG_englisch.pdf

§ 29 Medical Devices Vigilance System § 30 Safety officer for medical devices § 31 Medical devices consultant Part Six Competent authorities, ordinances, miscellaneous provisions …

5 things to know about the German medical device market

https://www.medicaldevice-network.com/analysis/german-medical-device-market/

German medical devices have to comply with the EU-wide regulations of the CE mark, which must be obtained for all devices sold with an intended medical …

Medical Devices Law - DIMDI

https://www.dimdi.de/dynamic/en/medical-devices/medical-devices-law/

Medical Devices Medical Devices Law Important notice As part of the merger of DIMDI with BfArM, contents of this website have been moved to the website www.bfarm.de. …

European Authorized Representative | EU …

https://mdss.com/about/

and Your Best EU Authorized Address. An Authorized Representative, MDSS is the main contact for the European Commission, National Competent Authorities, and is your EU …

EU Authorized Representative Services For Medical …

https://mdss.com/

The MDSS team offers different solutions for manufacturers to be in compliance with the European Medical Device (MDR (EU) 2017/745) and In-Vitro Device …

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

Medical Device Safety Plan Ordinance (MPSV) There are a multitude of possible reasons why a product does not work in line with the instructions. Efficient risk …

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