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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- The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively...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
- An official website of the European Union Public Health Home Medical Devices - New regulations Medical Devices - New regulations Overview The EU has …
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 ...
Medical devices - Internal Market, Industry, Entrepreneurship and …
- https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards/medical-devices_en
- Guidelines related to medical devices regulations; European Commission contact point: Directorate-General for Health and Food Safety Medical devices Email Webpage on …
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 …
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 …
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 …
European Commission proposes significant changes …
- https://www.insideeulifesciences.com/2023/01/09/european-commission-proposes-significant-changes-to-transition-timelines-of-the-medical-device-regulation-and-ivd-regulation/
- European Commission proposes significant changes to transition timelines of the Medical Device Regulation and IVD Regulation. Further to our discussion on the European Commission’s …
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