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Scope
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Directive 90/385/EEC aims to protect the human health and safety, smooth operation of the single market and to achieve the results for which the active implantable medical devices are intended.
The devices must not present risk to patients, medical personnel or others in contact with them. Every device must bear standard information, where possible by using recognised symbols, on its sterile pack and sales packaging.
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Legal act
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Directive 90/385/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 90/385/EEC
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Legal act repealed
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Directive 79/196/EEC (as at last amended by Directive 90/487/EEC)
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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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