German Medical Device Act

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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 - Laws and ordinances

https://www.bfarm.de/EN/Medical-devices/Overview/Laws-and-ordinances/_node.html

Medical devices Medical devices in overview Overview Regulatory framework Laws and ordinances Institutions Europe and EUDAMED Tasks of the BfArM Clinical investigations …

Act amending the Regulations governing Medical …

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

The purpose of the present Act is to regulate the trade in medical devices and, by doing so, to guarantee the safety, suitability and performance levels of medical devices …

German national requirements for medical devices - MDlaw

https://mdlaw.eu/mdr/german-national-requirements-for-medical-devices/

on September 28, 2021. The Medical Devices EU Adaptation Act (MPEUAnpG) and the Medical Devices Implementation Act (MPDG) The new …

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. …

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

Device Act, the Ordinance on Medical Devices (Verordnung über Medizinprodukte, MPV), the Medical Device Safety Plan Ordinance (Medizinprodukte …

Medical Device Law Implementation Act (MPDG) Definition - Arena

https://www.arenasolutions.com/resources/glossary/medical-device-law-implementation-act/

The Medical Device Law Implementation Act (MPDG) is the latest set of regulations that applies to companies that manufacture, distribute or market medical devices in …

German Medical Devices Act (Medizinproduktegesetz – MPG)

https://beoberlin.de/german-medical-devices-act-medizinproduktegesetz-mpg/?lang=en

German Medical Devices Act (Medizinproduktegesetz – MPG) The German Medical Devices Act (MPG) of 2 August 1994 ( Bundesgesetzblatt [German Legal Gazette] I p. 1963) …

Medical Device Regulations in Germany | RegDesk

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 Directives (MDD) soon to be replaced by the EU Medical Device …

Medicinal Products Act (Arzneimittelgesetz – AMG) - Gesetze im …

https://www.gesetze-im-internet.de/englisch_amg/

Medicinal Products Act (Arzneimittelgesetz – AMG) Medicinal Products Act (Arzneimittelgesetz – AMG) Full text in format: HTML PDF Übersetzung durch den …

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