Europa Medical Device

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The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively...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

Medical devices | European Medicines Agency

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

Medical devices legislation. The Regulations on Medical Devices ( Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices ( Regulation (EU) …

Medical Devices - EUDAMED - Public Health

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

EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746… Actors …

Medical devices - Internal Market, Industry, Entrepreneurship and …

https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards/medical-devices_en

Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the …

Medical Devices - Sector - Latest updates - Public Health

https://health.ec.europa.eu/medical-devices-sector/latest-updates_en

MDCG 2021-22 rev.1 - Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the …

Medical Devices - New regulations - Public Health

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

Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices General publications 10 July 2020 State of play of …

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) …

Medical Devices - New regulations - Latest updates

https://health.ec.europa.eu/medical-devices-new-regulations/latest-updates_en

European Medical Device Nomenclature (EMDN) - Questions and Answers News announcement 26 May 2021 Stronger rules on medical devices News …

Medical Devices - Expert Panels - Public Health

https://health.ec.europa.eu/medical-devices-expert-panels_en

Public Health Home Medical Devices - Expert Panels Medical Devices - Expert Panels Overview Regulation (EU) 2017/745 on Medical Devices (MDR) and …

Harmonised standards - Public Health

https://health.ec.europa.eu/medical-devices-topics-interest/harmonised-standards_en

Medical Devices - Topics of Interest Harmonised standards Once their references are published by the Commission in the Official Journal of the European …

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