European Council Medical Device Directive

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EUR-Lex - 32017R0745 - EN - EUR-Lex - Europa

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745

Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regulatory framework for medical devices, other than in vitro diagnostic medical devices. However, a fundamental revision of those Directives is needed to establish a …

B COUNCIL DIRECTIVE 93/42/EEC of 14 June …

https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:en:PDF

COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the …

Council Directive 93/42/EEC of 14 June 1993 concerning medical …

https://www.legislation.gov.uk/eudr/1993/42/2020-12-31

Whereas Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable …

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 Directive - Wikipedia

https://en.wikipedia.org/wiki/Medical_Devices_Directive

New Regulations - Public Health

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

With effect from 26 May 2022, Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices replaces Directive …

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 …

The European Union Medical Device Regulation – …

https://eumdr.com/

The Medical Device Coordination Group (MDCG), which has many responsibilities in the new Regulation, has now been established. It is listed in the register of Commission …

2019 - 2024 - europarl.europa.eu

https://www.europarl.europa.eu/doceo/document/TA-9-2023-0052_EN.pdf

5 Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 189, 20.7.1990, p. …

MDR transition delay approved by EU Parliament and Council

https://www.medicaldesignandoutsourcing.com/mdr-transition-delay-approved-eu-parliament-council/

2 days ago · The European Parliament and Council today voted to approve a Medical Device Regulation (MDR) transition delay in an effort to avoid shortages. The move gives …

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