European Medical Device

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Medical devices | European Medicines Agency

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

The Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746) changed the European legal framework for medical devices, introducing new responsibilities for EMA and national …

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 …

Medical Devices - Sector - Public Health

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

The EU revised the laws governing medical devices and in vitro diagnostics to align with the developments of the sector over the last 20 years. Latest updates. News …

Medical Devices - New regulations - Public Health

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

26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EU. News announcement; 26 May 2021; Notice to …

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

Medical Devices - Sector - Latest updates. MDCG 2021-22 rev.1 - Clarification on “first certification for that type of device” and corresponding procedures to …

The European Union Medical Device Regulation – …

https://eumdr.com/

A second c orrigendum to Regulation (EU) 2017/745 was published in the Official Journal of the European Union. Probably the most significant change being the extension of the …

Medical devices market in Europe 2021 …

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

Research expert covering health & pharmaceuticals in the UK & Europe. Get in touch with us now. , Dec 8, 2022. In 2021, the medical devices market …

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 …

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 …

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