Published: 29 August 2017

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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Legal act repealed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 82/130/EEC

Directive 79/196/EEC (as at last amended by Directive 90/487/EEC)

Directive 76/117/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, September 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 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable 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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Published: 29 August 2017

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Scope

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Regulation (EU) 2016/425 lays down requirements for the design and manufacture of personal protective equipment (PPE). It aims to ensure the health and safety of users and to allow the equipment to be sold and used throughout the EU.

The PPE may only be sold and used if it complies with the regulation, when properly maintained and used for its intended purpose, complies with the essential health and safety requirements of the regulation and does not endanger the health or safety of people, pets or property.

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Legal act

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Regulation (EU) 2016/425

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Consolidated act

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31/03/2016 (Languages available: FR, NL, SL, SV)

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Legal act repealed

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Directive 89/686/EEC

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Guidelines

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PPE Regulation (EU) 2016/425 Guidelines, April 2018

Regulation (EU) 2016/425 on personal protective equipment - Guidance document on the implementation of Article 47 on transitional provisions

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Previous Guidelines

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PPE Guidelines - Guide to application of the PPE Directive 89/686/EEC, version 24 August 2017

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National references

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Harmonisation standards

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Corrigendum to Commission communication in the framework of the implementation of Regulation (EU) 2016/425 of the European Parliament and of the Council on personal protective equipment and repealing Council Directive 89/686/EEC - OJ C 222 of 26/06/2018

Commission communication in the framework of the implementation of Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC - OJ C 209 of 15/06/2018

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More

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Guidance on CE marking for professionals

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Published: 29 August 2017

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Scope

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Directive 2000/9/EC defines a set of essential safety requirements at the EU level as well as inspection and control procedures to be applied to cableways that carry passengers. The installations subjected are funicular railways or other vehicles where traction is provided by one or more cables, cable cars lifted and/or displaced by carrier cables, including gondolas and chair lifts and draglifts.

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Legal act

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Regulation EU_2016_424 Regulation (EU) 2016/424

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Consolidated act

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31/03/2016

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Legal act repealed

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Directive 2000/9/EC

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Guidelines

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-

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Previous Guidelines

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Directive on cableway installations designed to carry persons - Application guide - Directive 2000/9/EC, 13 March 2006

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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 Regulation (EU) 2016/424 of the European Parliament and of the Council of 9 March 2016 on cableway installations and repealing Directive 2000/9/EC - OJ C 114 of 28/03/2018

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More

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Guidance on CE marking for professionals

The Cableway Installations Regulations 2018 - Guidance, July 2018 - Department for Transport UK

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Published: 29 August 2017

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Scope

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Directive 2014/90/EU aims to improves safety at sea, to prevent marine pollution and to ensure that international safety standards for equipment on EU ships are interpreted in the same way across the EU. It applies to all ships flying an EU flag. The equipment that meets the safety standards is stamped with a certification mark (the ‘wheel mark’) or alternatively the manufacturers may attach an electronic tag to their products. This should prevent counterfeiting and support in monitoring the market.

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Legal act

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Directive 2014/90/EU

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Consolidated act

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17/09/2014

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Legal act repealed

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Directive 96/98/EC

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Guidelines

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-

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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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Commission Delegated Regulation supplementing Directive 2014/90/EU of the European Parliament and of the Council as regards the identification of specific items of marine equipment which can benefit from electronic tagging, 09 January 2018

Annex to the Commission Delegated Regulation supplementing Directive 2014/90/EU of the European Parliament and of the Council as regards the identification of specific items of marine equipment which can benefit from electronic tagging, 09 January 2018

Guidance on the Inventory of Hazardous Material - IHM Development and Maintenance in the context of the EU Ship recycling Regulation - EMSA, 2017

Copernicus Maritime Surveillance Product Catalogue - EMSA, 2017

Inventory of EU Member States Oil Pollution Response Vessels, 2016

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