Medical Devices European Regulations

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Medical devices | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

Jan 25, 2023

New Regulations - Public Health

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

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

Medical Devices - New regulations Overview The EU has revised the legal framework of 3 directives to reflect progress over the last 20 years. Getting ready …

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, …

Medical Devices - Sector - Public Health

https://health.ec.europa.eu/medical-devices-sector_en

The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively... New …

Guidance - MDCG endorsed documents and other guidance

https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en

Borderline and Classification Class I Devices Clinical investigation and evaluation COVID-19 Custom-Made Devices EUDAMED European Medical Device Nomenclature (EMDN) …

European Medical Device Regulation | Deloitte Netherlands

https://www2.deloitte.com/nl/nl/pages/risk/articles/european-medical-device-regulation.html

The European Medical Device Regulation 2017/745 (EU-MDR) provides a regulatory framework with the purpose of ensuring safe and effective performance of medical …

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, …

Download MDR - Medical Device Regulation

https://www.medical-device-regulation.eu/download-mdr/

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and …

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