Published: 29 August 2017

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Scope

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Directive 2006/42/EC enables machinery that meets its health and safety requirements to be moved freely throughout the EU. This means that workers and the public are protected when they use or come into contact with machinery. It only applies to products when they are first placed on the EU market.

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Legal act

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Directive 2006/42/EC

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Consolidated act

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20/04/2016

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Legal act repealed

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Directive 98/37/EC

Directive 89/392/EEC

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Guidelines

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Guide to application of the Machinery Directive 2006/42/EC - Edition 2.1, July 2017

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Previous Guidelines

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Guidance on the application of the essential health and safety requirements on ergonomics set out in section 1.1.6 of Annex I to the Machinery Directive 2006/42/EC, Ref. 25 March 2015

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National references

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Harmonisation standards

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Commission Implementing Decision (EU) 2019/436 of 18 March 2019 on the harmonised standards for machinery drafted in support of Directive 2006/42/EC of the European Parliament and of the Council C/2019/1932 - OJ L 75, 19 March 2019, p. 108–119

Commission communication in the framework of the implementation of the Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast) - OJ C 092 of 9 March 2018

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More

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Guidance on CE marking for professionals

Evaluation Study of Directive 2006/42/EC on Machinery, September 2017

Machinery: update of the Guide to application of Machinery Directive 2006/42/EC

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Published: 29 August 2017

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Scope

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Directive 2000/14/EC harmonizes the existing legal instruments on noise emissions for construction plant and equipment, as well as a directive on lawnmowers. It aims to improve the control of noise emissions by different types of equipment used outdoors, such as compressors, excavator-loaders, different types of saws, mixers, etc.

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Legal act

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Directive 2000/14/EC

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Consolidated act

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20/04/2009

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Legal act repealed

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-

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Guidelines

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Guidelines for the application of Directive 2000/14/EC of the European Parliament and of the Council of 8 May 2000 on the approximation of the laws of the Member States relating to the noise emission in the environment by equipment for use outdoors, June 2017

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Previous Guidelines

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-

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National references

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Harmonisation standards

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-

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More

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Supporting study for an evaluation and impact assessment of Directive 2000/14/EC on noise emission by outdoor equipment, October 2018

Noise emission by equipment for use outdoors: Application Guide published in June 2017

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Published: 29 August 2017

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Scope

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Directive 2014/53/EU sets out rules for putting radio equipment on the EU internal market. It aims to keep pace with the growing number and variety of radio equipment devices and ensure that they do not interfere with each other and respect essential health and safety requirements.

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Legal act

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Directive 2014/53/EU

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Consolidated act

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11/09/2018

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Legal act repealed

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Directive 1999/5/EC

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Guidelines

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Guide to the Radio Equipment Directive 2014/53/EU, version of 19 December 2018

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Previous Guidelines

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Guide to the Radio Equipment Directive 2014/53/EU, version of 19th May 2017

Guide to the R&TTE Directive 1999/5/EC, version of 20 April 2009

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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 Directive 1999/5/EC of the European Parliament and of the Council on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity and Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC - OJ C 326 of 14/09/2018

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More

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Guidance on CE marking for professionals

Radio Equipment Directive (RE-D): FAQs on Directive 2014/53/EU

Commission Delegated Regulation (EU) 2019/320 of 12 December 2018 supplementing of Directive 2014/53/EU of the European Parliament and of the Council with regard to the application of the essential requirements referred to in Article 3(3)(g) of that Directive in order to ensure caller location in emergency communications from mobile devices, 25 February 2019

Commission Implementing Regulation specifying how to present the information provided for in Article 10(10) of Directive 2014/53/EU, 20 July 2017

Annexes to the Commission Implementing Regulation specifying how to present the information provided for in Article 10(10) of Directive 2014/53/EU, 20 July 2017

Commission staff working document - Executive summary of the impact assessment, 17 October 2012

Commission staff working document - Impact assessment, 17 October 2012

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Published: 29 August 2017

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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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-

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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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