Eu Directive Medical Devices

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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 Device Regulation comes into application

https://www.ema.europa.eu/en/news/medical-device-regulation-comes-application

Medical Device Regulation comes into application. Regulation (EU) 2017/745 on medical devices becomes applicable in the European Union today, 26 May …

Directives - Public Health

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

The European Union Medical Device Regulation – …

https://eumdr.com/

Publication of (EU) 2021/2226 Commission Implementing Regulation (EU) 2021/2226 on electronic instructions for use of medical devices. Publication of MDCG 2021-28 …

Medical Devices Directive - Wikipedia

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

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

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

Without prejudice to Article 2(2) of Directive 2001/83/EC, upon a duly substantiated request of a Member State, the Commission shall, after consulting the Medical Device …

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

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

medical device as a general rule is governed by the present Directive and the placing on the market of the medicinal product is governed by Directive 65/65/EEC; …

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The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively...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

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 …

EU Medical Device Directives - 6 Key Elements to Ensure …

https://www.complianceonline.com/resources/eu-medical-device-directives-key-elements.html

At present, the EU's regulatory framework for medical devices includes the following directives: Council Directive 90/385/EEC on active implantable medical devices …

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