European Commision Medical Devices

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Medical Devices - Sector - Public Health

https://health.ec.europa.eu/medical-devices-sector_en

The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively... New Regulations The EU revised the laws governing medical devices and in vitro diagnostics to align with …

Medical devices | European Medicines Agency

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

Jan 25, 2023

Medical Devices - New regulations - Public Health

https://health.ec.europa.eu/medical-devices-new-regulations_en

Manufacturer IVD. Manufacturers MD. Manufacturers of devices without an intended medical purpose. Healthcare professionals and health institutions. The …

Public Health: medical devices - ec.europa.eu

https://ec.europa.eu/commission/presscorner/detail/en/ip_23_23/smo

Public health: more time to certify medical devices to mitigate risks of shortages. Highlights, press releases and speeches ...

European Medical Device Nomenclature (EMDN)

https://webgate.ec.europa.eu/dyna2/emdn/

Per Article 26 of Regulation (EU) 2017/745 on medical devices (MDR) and Article 23 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), the European …

In Vitro Diagnostic Medical Devices Regulation

https://ec.europa.eu/commission/presscorner/detail/en/ip_21_6965/smo

Progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation. Highlights, press releases and speeches ...

European Commission Issues MDR Factsheet for …

https://www.emergobyul.com/news/european-commission-issues-mdr-factsheet-class-i-medical-device-manufacturers

The factsheet covers Class I devices currently marketed in Europe under Medical Device Directive 93/42/EEC, as well as new devices to be commercialized under the MDR. Quality management system work …

MDR transition delay approved by EU Parliament and Council

https://www.medicaldesignandoutsourcing.com/mdr-transition-delay-approved-eu-parliament-council/

2 days ago · The European Parliament and Council today voted to approve a Medical Device Regulation (MDR) transition delay in an effort to avoid shortages. The move gives …

Device makers gain more time to adapt to Europe’s MDR after …

https://www.medtechdive.com/news/EU-European-Parliament-MDR-extension/643064/

1 day ago · The European Parliament on Thursday voted overwhelmingly to delay implementation of the new Medical Device Regulation, or MDR. The 537-3 vote gives …

European Parliament votes to extend MDR transition period

https://www.raps.org/news-and-articles/news-articles/2023/2/european-parliament-votes-to-extend-mdr-transition

2 days ago · Vollebregt added that the European Parliament may also want to call on the EU Commission to adopt additional legislation to fix problems that persist in the device …

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