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Medical devices | European Medicines Agency
- https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
- The Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746) changed the European legal framework for medical devices, introducing new responsibilities for EMA and national …
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
- Medical Devices - New regulations; Medical Devices - New regulations. Overview. The EU has revised the legal framework of 3 directives to reflect progress over …
Medical Device Regulation comes into application
- https://www.ema.europa.eu/en/news/medical-device-regulation-comes-application
- The Medical Device Regulation (MDR), which was adopted in April 2017, changes the European legal framework for medical devices and introduces new principal …
The European Union Medical Device Regulation – …
- https://eumdr.com/
- A second c orrigendum to Regulation (EU) 2017/745 was published in the Official Journal of the European Union. Probably the most significant change being the extension of the …
European Parliament votes to extend MDR transition period
- https://www.raps.org/news-and-articles/news-articles/2023/2/european-parliament-votes-to-extend-mdr-transition
- 2 days ago · The European Parliament on Thursday voted overwhelmingly to extend the Medical Devices Regulation (MDR) transition periods to avoid a shortage of life-saving …
New Medical Device Regulation in Europe
- https://www.fusfoundation.org/posts/new-medical-device-regulation-in-europe/
- On May 26, 2021, the European Union (EU) implemented REGULATION (EU) 2017/745, the “Medical Device Regulation,” or MDR. After its first year in existence, the medtech community’s initial concerns …
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 …
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, …
Breaking News: EU Votes to Amend Medical Device …
- https://www.linkedin.com/pulse/breaking-news-eu-votes-amend-medical-device-regulation-
- Medical device manufacturers have new deadlines to meet in order to comply with the amended regulation. To review the full document please visit this …
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