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Scope
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Directive 98/79/EC provides a high level of protection for the health and safety of patients, users and others and ensures the devices achieve the results for which they are intended. It sets out the essential safety, health, design and manufacturing requirements that in vitro diagnostic medical devices and their accessories must meet.
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Legal act
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Directive 98/79/EC until 25/05/2020 (Partial end of validity. See: Regulation (EU) 2017/746 Art. 112), after Regulation (EU) 2017/746 (already in force)
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Consolidated act
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11/01/2012 of Directive 98/79/EC
05/05/2017 of Regulation (EU) 2017/746
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Legal act repealed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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