CE Marking News and Articles

European databank for medical devices to boost control

A European Commission decision adopted on April 19 will oblige all EU countries to use, as of May 2011, a European databank for medical devices (Eudamed). Medical devices range from life-supporting devices such as pacemakers through hip implants or X-ray machines, down to products used daily such as syringes or blood tests. Even though these devices are traded on the European single market, data which are key to their safety – such as conformity certificates, data on clinical investigations – are for the time being collected only at the national level. The Eudamed databank is a secure IT tool which will ensure rapid access to such data by market surveillance authorities. The databank will also streamline the rules for manufacturers placing in vitro diagnostic (IVD) devices on the market.

Annual Inspection Report shows efficiency of EU’s cooperation on dangerous products

Brussels April 15 2010 – The number of dangerous consumer products notified through the EU’s rapid alert system for non-food dangerous products (“RAPEX”) rose by 7% in 2009 compared to 2008, the Commission’s annual RAPEX report shows today. This rise from 1866 notifications in 2008 to 1993 last year shows that the capacity of the RAPEX system has increased again in 2009, following more effective market surveillance by Member States. European businesses are also taking their responsibilities in the consumer product safety area more seriously and recall their unsafe products from the market more readily. They also begin to use the dedicated rapid alert system for business (‘Business Application’) more systematically. Toys, clothing and motor vehicles were the most frequently notified products in 2009. In addition, the results of an EU market surveillance exercise, involving 13 countries checking the safety of toys, were also presented today, and show that around 20% did not comply with the relevant safety requirements.

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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Closer cooperation between US and EU needed?

In 2007 EU Commission President Jose Manuel Barroso stated at a EU-US summit that “The reality is that the world is safer and more prosperous when Europe and America work together as global partners”.

The large number of unsafe and counterfeit products flooding to our markets, and recalls like we had with Mattel and Fisher Price products have caused outrage with consumers in North America and Europe. Many politicians have called for immediate action. In the European Parliament there were even voices that called for the CE marking system to be reversed.

Protecting European consumers

The basic aim of consumer protection policy in the EU is to inform and empower consumers, ensuring they are equally well-protected across the 27 EU Member States with the European Commission working in synergy with the National Authorities. EU rules curb abusive practices, harmonize legislation in the financial services and monitor product safety (via the RAPEX alert system).