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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- The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively...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 | 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 …
Medical Devices - Sector - Latest updates - Public Health
- https://health.ec.europa.eu/medical-devices-sector/latest-updates_en
- MDCG 2021-22 rev.1 - Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the …
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 - 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 …
New Regulations - Public Health
- https://health.ec.europa.eu/medical-devices-sector/new-regulations_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. The priority was to ensure …
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 ...
Getting ready for the new regulations - Public Health
- https://health.ec.europa.eu/medical-devices-new-regulations/getting-ready-new-regulations_en
- The new regulations create a robust, transparent, and sustainable regulatory framework, recognised internationally, that improves clinical safety and creates fair market …
The European Union Medical Device Regulation – …
- https://eumdr.com/
- Publication of MDCG 2021-24 Guidance on classification of medical devices. The EUDAMED UDI/Devices and NBs & Certificates modules are now open for economic …
MDR transition delay approved by EU Parliament and Council
- https://www.medicaldesignandoutsourcing.com/mdr-transition-delay-approved-eu-parliament-council/
- 2 days ago · “I welcome today’s [European Parliament] vote to extend the transition period to new rules under the Medical Devices Regulation,” Commissioner for Health and Food …
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