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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Legal act repealed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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Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a ‘person responsible for regulatory compliance’ (PRRC), June 2019

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

Guidelines on Medical Devices - IVD Medical Device Borderline and Classification issues - A Guide for manufacturers and Notified Bodies, January 2012

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National references

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Harmonisation standards

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Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices - OJ C 389 of 17/11/2017

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More

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Guidance on CE marking for professionals

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