List European Harmonized Standards for the Medical Devices Directives (93/42/EEC, 90/385/EEC, and 98/79/EC) Updated

On Friday 27 April 2012, the European Commission published updated lists of the European harmonized standards that pertain to the Medical Devices Directive (93/42/EC), In Vitro Diagnostics Directive (98/79/EC), and the Active Implantable Medical Devices Directive (90/385/EEC). The standards on these lists may be used by manufacturers to prove that their equipment complies with the essential requirements of this directive.

The updated list are important to all manufacturers of CE marked medical devices, active implantable medical devices and in vitro diagnostics that have used European harmonized standards to prove CE compliance. If you have applied standards to prove compliance with the aforementioned directives, re-evaluate your products against the updated standards and update your Declaration of Conformity.

Have your say: Evaluation of the Pressure Equipment Directive 97/23/EC

The primary objective of the Pressure Equipment Directive is to guarantee free circulation of stationary pressure equipment within the Internal Market whilst ensuring a high degree of safety. It is now over nine years since the Directive entered into force and the European Commission is evaluating its performance. The evaluation is being conducted by the Centre for Strategy & Evaluation Services (CSES). A report on the evaluation will be made available on the DG Enterprise and Industry website later in Autumn 2012.

As part of the Evaluation, CSES is collecting information from businesses and stakeholders about their perceptions of the performance of the Pressure Equipment Directive. The survey should take 10-15 minutes to complete.
There are two surveys, one for businesses involved in the production/ use of pressure equipment and one for stakeholders e.g. notified bodies, government authorities, standardisation experts or bodies, pressure equipment experts or institution and other stakeholders.

European Commission updates list of European Harmonized Standards for the Pressure Equipment Directive (97/23/EC) and Simple Pressure Vessels Directive (2009/105/EC)

Wednesday April 11 was a busy day for the European Commission. Besides the list of harmonized standards for the EMC Directive (2004/108/EC) and Radio and Telecommunication Terminal Equipment (RTTE) Directive (99/05/EC), the Commission also published updates to the lists of the European harmonized standards that pertain to the Pressure Equipment Directive (97/23/EC) and the Simple Pressure Vessels Directive (2009/105/EC). The standards on these list may be used by pressure equipment manufacturers to prove that their equipment complies with the essential requirements of these directives.

European Commission updates list of European Harmonized Standards for the EMC Directive (2004/108/EC)

Earlier today, the European Commission published an updated list of the European harmonized standards that pertain to the EMC Directive (2004/108/EC). The standards on this list may be used by electronics and electrical equipment manufacturers to prove that their equipment complies with the essential requirements of this directive.

European Commission updates list of European Harmonized Standards for the Machinery Directive (2006/42/EC)

On 29 February, the European Commission published an updated list of the European harmonized standards that pertain to the Machinery Directive (2006/42/EC). The standards on this list may be used by machinery manufacturers to prove that their machinery complies with the essential requirements of this directive.

REACH, European rules for chemicals

In 2007, the EU introduced new rules for the chemical industry — the REACH package — are set to improve our health and protect the environment. Obliging companies to register and provide information on the chemicals they use should enable public authorities to identify their properties more quickly and accurately. Particularly severe on toxic products, the new rules will encourage the European chemicals industry to develop new substances that are less harmful for people and the environment. As a result, the sector itself should also gain a lead in innovative and sustainable technologies.

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