German Act On Medical Devices

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BfArM - Medical devices

https://www.bfarm.de/EN/Medical-devices/_node.html

The tasks of BfArM in the field of medical devices result in particular from the Medical Device Regulation ( MDR) ( EU) 2017/745, the Medical Device Law Implementation Act, the “Medizinprodukterecht-Durchführungsgesetz” ( MPDG ), the Medical Devices Act “Medizinproduktegesetz” ( MPG) and the further implementing legal ordinances.

BfArM - Laws and ordinances

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

For German national laws and ordinances, please visit the German site. European directives and regulations. Regulation (EU) 2017/745 on medical devices, amending …

Act amending the Regulations governing Medical …

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

The Act on Medical Devices non-official translation (Medical Devices Act) _____ Status: 30.03.2011 Page 1 of 57 The Act on Medical Devices (Medical Devices Act) ... In other …

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

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

Division 1Purpose of the Act, definition of terms, scope. Section 1 Purpose of the Act. Section 2 The term ‘medicinal product’. Section 3 The term ‘substance’. Section 4 …

German national requirements for medical devices - MDlaw

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

The Medical Devices EU Adaptation Act (MPEUAnpG) and the Medical Devices Implementation Act (MPDG) The new Regulation (EU) 2017/745 (MDR) entails …

Medical Devices Law - DIMDI

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

As part of the merger of DIMDI with BfArM, contents of this website have been moved to the website www.bfarm.de.. Information on the topic "Medical Devices Law" can now be …

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-Sicherhetsplanverordnung, …

Q&A: pharma & medical device regulation in Germany

https://www.lexology.com/library/detail.aspx?g=4e521a96-5e31-43f8-a45e-e4d080d32452

A Q&A guide to pharma & medical device regulation in Germany, covering the healthcare bodies and competent authorities, marketing authorisation, defective and …

Medical Device Regulations in Germany

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

The Federal Institute for Drugs and Medical Devices ( Bundesinstitut für Arzneimittel und Medizinprodukte ), BfArM, is the institution responsible for …

Germany - Healthcare and Medical Technology

https://www.trade.gov/country-commercial-guides/germany-healthcare-and-medical-technology

The German medical device market is one of the most lucrative healthcare markets worldwide, accounting for roughly USD 35.8 billion annually, or 25.6 percent of …

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