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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Legal act repealed

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Directive 76/764/EEC

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Guidelines

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Medical Devices: Guidance document - Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, June 2019

Medical Devices: Guidance document - Qualification and Classification of stand alone software, July 2016

Guidelines on Medical Devices - Clinical Evaluation: a Guide for Manufacturers and Notified Bodies under Directives 93/42/EEC and 90/385/EEC, June 2016

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Previous Guidelines

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Guidelines on Medical Devices - Guidelines for competent authorities for making a validation/assessment of a clinical investigation application under Directives 93/42/EEC and 90/385/EEC, 12 October 2015

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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Commission communication in the framework of the implementation of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices - OJ C 389 of 17/11/2017

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More

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Guidance on CE marking for professionals

Commission Implementing Regulation laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards common specifications for the reprocessing of single-use medical devices, 2019

Statement of the Council’s reasons: Position (EU) No 2/2017 of the Council at first reading with a view to the adoption of a Regulation of the European Parliament and of the Council on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC - C 116/197, 11 April 2017

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