Proposed New European Medical Device Regulations

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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 …

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 Devices - New regulations - Public Health

https://health.ec.europa.eu/medical-devices-new-regulations_en

The EU has revised the legal framework of 3 directives to reflect progress over the last 20 years. Getting ready Manufacturer IVD Manufacturers MD Manufacturers …

European Commission Pushes to Extend MDR Deadlines

https://www.mddionline.com/regulatory-quality/european-commission-pushes-extend-mdr-deadlines

Under the proposal, high risk devices such as pacemakers and hip implants would need to comply with the MDR by December 2027, while medium and low risk …

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 and …

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

The European Union Medical Device Regulation (EU MDR) was first enacted in 2017. At the time, the implementation periods looked ambitious but …

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, …

The European Union Medical Device Regulation – …

https://eumdr.com/

The EU Commission published three new Factsheets describing the implications of the new Regulations on various stakeholders: (1) Factsheet for Authorised Representatives, …

European Commission proposes to delay EU MDR …

https://www.massdevice.com/european-commission-delays-eu-mdr-deadline-until-2028/

The European Union’s Health Commissioner today proposed pushing back the deadline for its new medical device regulation (MDR) law. Reuters first reported the news yesterday and confirmed...

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