European Medical Devices Directive

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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 …

Directives - Public Health

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

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 …

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; …

The European Union Medical Device Regulation – …

https://eumdr.com/

Publication of MDCG 2021-24 Guidance on classification of medical devices. The EUDAMED UDI/Devices and NBs & Certificates modules are now open for economic …

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The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively...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

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 …

EU Medical Device Directives - 6 Key Elements to Ensure …

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

EU Medical Device Directives - 6 Key Elements to Ensure Compliance Ensure products fulfill the EU's unique regulatory requirements by understanding key elements that can …

What Is the EU Medical Devices Directive? | Assent

https://www.assent.com/resources/knowledge-article/what-is-the-eu-medical-devices-directive/

The European Union (EU) Medical Devices Directive (MDD) was introduced in 1994 to regulate medical devices sold in the EU. The MDD is based on the principles of the …

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