European Medical Devices

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Medical devices | European Medicines Agency

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

Jan 25, 2023

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The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively...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

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 …

EUDAMED database - EUDAMED - European Commission

https://ec.europa.eu/tools/eudamed/

The creation of a European database on medical devices (EUDAMED) is one of the key aspects of the new rules on medical devices ( Regulation (EU) 2017/745) and in vitro …

Medical Devices - Sector - Latest updates - Public Health

https://health.ec.europa.eu/medical-devices-sector/latest-updates_en

MDCG 2022-21 - Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 - December 2022 News announcement 16 …

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 …

Medical devices market in Europe 2021-2027 | Statista

https://www.statista.com/statistics/1350975/european-medical-devices-market/

Dec 8, 2022 In 2021, the medical devices market in Europe had a value of almost 146 billion U.S. dollars. By 2027, the market was forecast to reach over 204 billion U.S. dollars with a CAGR...

The European Union Medical Device Regulation – …

https://eumdr.com/

The European Commission published IMPLEMENTING DECISION (EU) 2019/939, designating four entities to assign Unique Device Identifiers (UDIs) to medical devices …

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 …

EU Agrees to Extend Transitional Periods for Medical …

https://www.sidley.com/en/insights/newsupdates/2023/02/eu-agrees-to-extend-transitional-periods-for-medical-devices-and-in-vitro-medical-devices

February 17, 2023 On February 16, 2023, the European Parliament adopted legislation that amends the transitional provisions of the European Union (EU) Medical …

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