European Medical Directive

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Medical devices | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

It repeals Directive 93/42/EEC on medical devices and the Directive 90/385/EEC on active implantable medical devices. The In Vitro Diagnostic Devices Regulation applies since 26 May 2022. It repeals Directive 98/79/EC of the European …

Medical Device Regulation comes into application

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

The MDR replaces the existing Directives for medical devices (93/42/EEC and 90/385/EEC). The Regulation on in vitro diagnostic medical devices, which also …

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

Regulation (EU) 2017/745 - Wikipedia

https://en.wikipedia.org/wiki/Regulation_(EU)_2017/745

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 basis of a …

The European Union Medical Device Regulation – …

https://eumdr.com/

A second c orrigendum to Regulation (EU) 2017/745 was published in the Official Journal of the European Union. Probably the most significant change being the extension of the …

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 …

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

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

B COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1) Amended by: Official Journal No page date M1 …

European directives on safety and health at work

https://osha.europa.eu/en/safety-and-health-legislation/european-directives

The most important legal act is the European Framework Directive (1989/391/EEC), which establishes general principles for managing safety and health, such as responsibility of …

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