Europa Medical Devices

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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The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively...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 - 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 | 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 Devices - New regulations - Public Health

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

An official website of the European Union Public Health Home Medical Devices - New regulations Medical Devices - New regulations Overview The EU has …

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 …

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 - 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 …

EUDAMED database - EUDAMED - European Commission

https://ec.europa.eu/tools/eudamed/

The creation of a European database on medical devices (EUDAMED) is one of the key aspects of the new rules on medical devices ( Regulation (EU) 2017/745) and in vitro …

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

This page provides a range of documents to assist stakeholders in applying Regulation (EU) 2017/745 on medical devices (MDR) Search for available translations of the preceding …

Medical devices - Internal Market, Industry, Entrepreneurship and …

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

Medical devices Medical devices Regulation (EU) 2017/745 Publications Publications in the Official Journal Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 …

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