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.

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.

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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