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Scope
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Directive 93/42/EEC aims to protect the human health and safety, smooth operation of the single market and to achieve the results for which the devices are intended.
National authorities must ensure that all medical devices available in the EU are safe for patients, users and others when they are properly installed, maintained and used as they should be.
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Legal act
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Directive 93/42/EEC until 25/05/2020 (Partial end of validity See Regulation (EU) 2017/745 Art. 122), after Regulation (EU) 2017/745 (already in force)
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Consolidated act
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05/05/2017 of Regulation (EU) 2017/745
11/10/2007 of Directive 93/42/EEC
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Legal act repealed
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Guidelines
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Medical Devices: Guidance document - Qualification and Classification of stand alone software, July 2016
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Previous Guidelines
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Guidelines on a Medical Devices vigilance system, January 2013
Additional Guidance Regarding the Vigilance System
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National references
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Harmonisation standards
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More
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Guidance on CE marking for professionals
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