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Medical Device Regulation comes into application
- https://www.ema.europa.eu/en/news/medical-device-regulation-comes-application
- Medical Device Regulation comes into application. Regulation (EU) 2017/745 on medical devices becomes applicable in the European Union today, 26 May 2021. The Medical Device Regulation (MDR), which was adopted in April 2017, changes …
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 …
New Regulations - Public Health
- https://health.ec.europa.eu/medical-devices-sector/new-regulations_en
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 …
MDR vs. MDD: 13 Key Changes - The FDA Group
- https://www.thefdagroup.com/blog/mdr-vs-mdd-13-key-changes
- The date of application (DoA) of the EU Medical Devices Regulation (EU MDR) has been set back one year to May 26, 2021. Why? To "relieve pressure on …
Breaking News: EU Votes to Amend Medical Device …
- https://www.linkedin.com/pulse/breaking-news-eu-votes-amend-medical-device-regulation-
- 1. Those devices must continue to comply with Directive 90/385/EEC or Directive 93/42/EEC, as applicable. 2. There are no significant changes in the design …
The European Union Medical Device Regulation – …
- https://eumdr.com/
- The Medical Device Coordination Group (MDCG), which has many responsibilities in the new Regulation, has now been established. It is listed in the register of Commission …
EU Medical Device Directive: 6 New Essential …
- https://medicaldeviceacademy.com/eu-medical-device-directive/
- The new ER 10 is expanded and references the new EU regulations regarding devices manufactured utilizing tissues or cells of animal origin: Commission Regulation (EU) No 722/2012 of August 8, …
New EU MDR Regulations and Revamp of the Medical …
- https://www.medtechintelligence.com/feature_article/new-eu-mdr-regulations-revamp-medical-device-directive/
- Jan 26, 2018
New Changes to the European Union's Medical Device …
- https://www.zasio.com/new-changes-european-union-medical-device-regulations/
- On May 26, 2020, the European Union enacted new regulations concerning medical and in vitro diagnostic devices—a move that should cause manufacturers, clinical trial sponsors, investigators, and other …
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