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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, …
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 European Regulation for Medical Devices: What Is …
- https://pubmed.ncbi.nlm.nih.gov/31123774/
- Materials and methods: In this paper, we describe the major transformation that the MDR brings to the medical devices sector, with a focus on clinical evaluations and clinical …
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 …
(PDF) European medical device regulation: a new era?
- https://www.researchgate.net/publication/7541679_European_medical_device_regulation_a_new_era
- December 2004 Medical Device Technology Maria E. Donawa By the spring of 2005, the European Commission hopes to present the first draft of the revisions to the …
The impact of new European Medical Device Regulations
- https://www.med-technews.com/medtech-insights/medtech-regulatory-insights/the-impact-of-new-european-medical-device-regulations/
- The impact of new European Medical Device Regulations. 22 November 2021. 00:01. The New Regulation (EU) 2017/745 for medical devices (MDRs), which went …
European Union: New Transition Timelines In EU And …
- https://www.mondaq.com/uk/life-sciences-biotechnology--nanotechnology/1283340/new-transition-timelines-in-eu-and-uk-medical-device-regimes
- 2 days ago · The European Union Medical Device Regulation (EU MDR) was first enacted in 2017. At the time, the implementation periods looked ambitious but achievable. The …
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 …
European medical device regulation: a new era?
- https://europepmc.org/article/MED/16225282
- Europe PMC is an archive of life sciences journal literature. European medical device regulation: a new era? Sign in | ... European medical device …
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, …
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