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The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively...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

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

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

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 …

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 …

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 commission approves delay in medical …

https://www.euronews.com/2023/01/07/eu-health-medicaldevices

LONDON – The European Commission said on Friday it approved delaying the deadline for companies to comply with a new law regulating medical devices in …

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: 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 ...

EU To Extend the Transitional Period of the Proposal Put Forth …

https://www.medicaltechoutlook.com/news/eu-to-extend-the-transitional-period-of-the-proposal-put-forth-into-mdr--nwid-2619.html

The European Commission has petitioned a new proposal and an extension in its transitional period concerning the Medical Devices Regulation. …

DocsRoom - European Commission

https://ec.europa.eu/docsroom/documents?keywords=medical%20device&locale=en

MDCG 2020-6 Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC. A …

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