European Commission Medical Devices Directive

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Directives - Public Health

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

The European Commission has adopted several implementing measures based on the medical devices directives. These measures concern, among other things, medical devices manufactured using tissues of animal origin, the classification of certain medical devices, and common technical specifications for … See more

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The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively...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

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 …

New Regulations - Public Health

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

The EU revised the laws governing medical devices and in vitro diagnostics to align with the developments of the sector over the last 20 years. ... 2017/746 on in vitro diagnostic …

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 …

Harmonised standards - Public Health

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

Harmonised standards under the medical devices Regulations are developed by CEN and CENELEC as European standardisation organisations, on the …

MEDICAL DEVICES : Guidance document

https://ec.europa.eu/docsroom/documents/10283/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. 1/5 …

The European Union Medical Device Regulation – …

https://eumdr.com/

The European Commission published IMPLEMENTING DECISION (EU) 2019/939, designating four entities to assign Unique Device Identifiers (UDIs) to medical devices …

GUIDELINES ON MEDICAL DEVICES - European …

https://ec.europa.eu/docsroom/documents/10336/attachments/1/translations/en/renditions/pdf

Cosmetics and Medical Devices MEDDEV 2.7/4 December 2010 GUIDELINES ON MEDICAL DEVICES GUIDELINES ON CLINICAL INVESTIGATION: A GUIDE FOR …

In Vitro Diagnostic Medical Devices Regulation

https://ec.europa.eu/commission/presscorner/detail/en/ip_21_6965/smo

Progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation. Highlights, press releases and speeches ...

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