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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 …
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 - 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- The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively... New Regulations …
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 …
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
- Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices General publications 10 July 2020 State of play of …
EU Classification of Medical Devices with examples
- https://omcmedical.com/eu-classification-of-medical-devices-with-examples/
- Around the world, the definition of medical devices varies. Still, generally, a medical device is any instrument, equipment, machine, appliance, implant, reagent for in …
New European MDCG Guidance on Medical Device Vigilance …
- https://www.emergobyul.com/news/new-european-mdcg-guidance-medical-device-vigilance-requirements
- The long-awaited Medical Device Coordination Group (MDCG) Guidance on Vigilance has been published to the European Commission website. MDCG 2023-3, …
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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