European Commission Public Health 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The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively...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 …

Medical Devices - EUDAMED - Public Health

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

EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746… Actors …

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 ...

New Regulations - Public Health

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

Medical Devices - New regulations - Public Health

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

An official website of the European Union Public Health Home Medical Devices - New regulations Medical Devices - New regulations Overview The EU has …

Public health: Stronger rules on medical devices

https://ec.europa.eu/commission/presscorner/api/files/document/print/en/ip_21_2617/IP_21_2617_EN.pdf

The Regulation on medical devices is complemented by the Regulation on in vitro diagnostic medicaldevices (2017/746/EU) with a date of application of 26 May 2022. In …

Public Health

https://health.ec.europa.eu/index_en

European Medicines Agency (EMA) Substances of human origin Blood, tissues, cells and organs Medical devices Sector New regulations In Vitro Diagnostics …

Public health - commission.europa.eu

https://commission.europa.eu/topics/public-health_en

The European Commission and EU countries are working together to build a strong European Health Union, which protects the health of Europeans, improves the resilience …

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 …

Public health: more time to certify medical devices to mitigate …

https://europeansting.com/2023/01/06/public-health-more-time-to-certify-medical-devices-to-mitigate-risks-of-shortages/

Today, the Commission adopted a proposal to give more time to certify medical devices to mitigate the risk of shortages. The proposal introduces a longer …

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