Eu Medical Device Directive 2022 47 Ec

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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 repeals Directive 93/42/EEC on medical devices and the Directive 90/385/EEC on …

Medical Devices - New regulations - Public Health

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

26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EU News announcement 26 May 2021 Notice to …

New Regulations - Public Health

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

Harmonised standards - Public Health

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

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

European Medical Device Regulation (EU MDR) …

https://eu.bd.com/iv-news/wp-content/uploads/2022/04/BD-54156-EU-MDR-Overview-Brochure-and-FAQ-2022.04.07-APPROVED-FOR-DISTRIBUTION-compressé.pdf

What is EU MDR? The European Medical Device Regulation (EU MDR) will replace the EU’s current Medical Device Directive (MDD) to ensure high standards of quality and …

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The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively...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

Directives - Public Health

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

Harmonised European standards under the medical devices Directives are developed by CEN and Cenelec as European standardisation organisations, on the basis of specific …

Medical devices - Internal Market, Industry, Entrepreneurship and …

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

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ L 169 of 12 July 1993. Applicable until 25.05.2021. See references published under Directive …

EUR-Lex - 32007L0047 - EN - EUR-Lex - Europa

https://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX%3A32007L0047

For the appropriate and efficient functioning of Directive 93/42/EEC as regards regulatory advice on classification issues arising at national level, in particular on whether or not a …

EUR-Lex - 31993L0042 - EN - EUR-Lex - Europa

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31993L0042

Whereas this Directive covers the medical devices referred to in Council Directive 76/764/EEC of 27 July 1976 on the approximation of the laws of the Member States on …

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