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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 repeals Directive 93/42/EEC on medical devices and the Directive 90/385/EEC on …
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 …
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 …
EU MDR Delay and Biocompatibility
- https://www.mddionline.com/regulations/eu-mdr-delay-what-does-it-mean-biocompatibility-and-chemical-characterization
- The year 2020 was already going to be an “exciting” one for medical device companies, thanks to all …
The European Union Medical Device Regulation – …
- https://eumdr.com/
- In October 2017 the Swiss parliament passed an interim act (Medizinprodukteverordnung (MepV)) that enables candidate Notified Bodies based …
Biological hazard applications: regulations and guidance …
- https://www.efsa.europa.eu/en/applications/biologicalhazard/regulationsandguidance
- Administrative guidance and support initiatives Applicable to applications submitted as of 27 March 2021 Administrative guidance for the processing of …
Biological Safety & European Medical Device Regulations
- https://books.google.com/books/about/Biological_Safety_European_Medical_Devic.html?id=YAKki28q0y8C
- acceptable activities adequate adverse allow application approach appropriate arising aspects assessor assurance Authority basis benefit biocompatibility biological …
The European Union In Vitro Diagnostics Regulation – …
- https://euivdr.com/
- Publication of MDCG 2022-10 Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 …
[PDF] Book Biological Safety European Medical Device …
- https://jaimesilva.co/pdf/biological-safety-european-medical-device-regulations/
- The new EU regulations on medical devices and in vitro diagnostic medical devices (IVDs) are changing the rules of the game in this important area of health care. It is now …
EU MDR’s Medical Device Biocompatibility …
- https://tsquality.ch/eu-mdrs-bio-compatibility-requirements-for-medical-devices-iso-10993/
- Regulatory bodies such as FDA, MHRA and European bodies emphasize on the medical devices to be bio-compatible. Bio-Compatibility of Dental Implants Regulatory …
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