Medical Device Regulations Germany

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

Com­ple­men­tary and Al­ter­na­tive Medicines (CAM) and Tra­di­tion­al Medic­i­nal Prod­ucts (TMP) Li­cens­ing Pro­ce­dures To overview: Licensing Procedures Cen­tralised …

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 …

Germany - Healthcare and Medical Technology

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

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 …

Q&A: pharma & medical device regulation in Germany

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

Germany December 10 2019 Health services framework and competent authorities Healthcare bodies Describe the bodies and their responsibilities (public and …

Germany Medical Device Registration - BfArM and …

https://arazygroup.com/medical-device-registration-germany/

In Germany, devices are regulated by the The Federal Institute for Drugs and Medical Devices (BfArM) and The German Institute of Medical Documentation and …

Medical devices | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

The Medical Devices Regulation applies since 26 May 2021. Manufacturers must comply with the Regulation when placing new medical devices on the market. It …

Medical Device Regulations in Germany

https://operonstrategist.com/medical-device-regulations-in-germany/

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

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. …