European Commission Medical Devices Unit

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Medical Devices - Sector - Public Health

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

Update - MDCG 2020-16 Rev.2 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 - February 2023. News announcement. 12 January 2023.

Medical Devices - EUDAMED - Public Health

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

On 1 December 2020 the European Commission has made available the Actor registration module.It is the first of six EUDAMED modules.EUDAMED… UDI/Devices registration …

Medical Devices - New regulations - Public Health

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

Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications in accordance with Regulation (EU) 2017/746. News …

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 | European Medicines Agency

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

The Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746) changed the European legal …

Public Health: medical devices - ec.europa.eu

https://ec.europa.eu/commission/presscorner/detail/en/ip_23_23/smo

Public health: more time to certify medical devices to mitigate risks of shortages. Highlights, press releases and speeches ...

The European Union Medical Device Regulation – …

https://eumdr.com/

The European Commission published the first Implementing Regulation related to the EU MDR and EU IVDR in the Official Journal of the EU. Regulation (EU) 2017/2185 contains …

MEDICAL DEVICES Guidance document …

https://ec.europa.eu/docsroom/documents/10337/attachments/1/translations/en/renditions/native

EUROPEAN COMMISSION . DG HEALTH AND CONSUMER . Directorate B, Unit B2 “Cosmetics and medical devices” MEDICAL DEVICES: Guidance document - …

MEDICAL DEVICES : Guidance document

https://ec.europa.eu/docsroom/documents/10285/attachments/1/translations/en/renditions/pdf

EUROPEAN COMMISSION DG ENTERPRISE Directorate G Unit 4 - Pressure Equipment, Medical Devices, Metrology MEDICAL DEVICES : Guidance document MEDDEV 2. 2/1 …

MEDICAL DEVICES : Guidance document

https://ec.europa.eu/docsroom/documents/10278/attachments/1/translations/en/renditions/pdf

EUROPEAN COMMISSION DG ENTERPRISE Directorate G Unit 4 - Pressure Equipment, Medical Devices, Metrology MEDICAL DEVICES : Guidance document MEDDEV 2. 1/1 …

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Medical Devices - Sector - Public Health

Medical Devices - EUDAMED - Public Health

Medical Devices - New regulations - Public Health

Medical Devices - Sector - Latest updates - Public Health

Medical devices | European Medicines Agency

Public Health: medical devices - ec.europa.eu

The European Union Medical Device Regulation – …

MEDICAL DEVICES Guidance document …

MEDICAL DEVICES : Guidance document

MEDICAL DEVICES : Guidance document

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