Dealers are not reponsible for faulty CE marked products

In a recent preliminary ruling the European Court of Justice decided that dealers are not required to ensure that an industrial product bearing a CE (European conformity) mark meets European health and safety requirements.

The aim of the CE mark, according to the Court, is to harmonise conformity rules and thus promote free movement of products. Holding dealers liable for defective products would impede that objective. However, if products are imported into a European Member State from a non-EU country the importer is considered a ‘manufacturer’ and thus must assume certain manufacturer liabilities.

This ECJ ruling constitutes an important support for dealers who are not ‘authorised representatives’ according to the Medical Devices Directive (93/42/EEC). The ruling does not affect the manufacturers of medical devices.

(Ref: C-40/04. Preliminary ruling. 8 September 2005)

01.07.2006

News • Threat to medical device availability

Cardiologists call for urgent MDR revision

While the Medical Device Regulation was designed to enhance safety and quality, its complexity and certification costs threaten the availability of vital devices. Cardiologists urge for revision.

News • Physicians' dilemma

Who is to blame for errors of medical AI?

Assistive AI systems are designed to ease the workload of physicians. However, implementation of the technology could actually worsen challenges related to error prevention and burnout, experts warn.

Article • A hard farewell from the lead apron

Radiation protection: Were we wrong all along?

For more than a year now, patients in Austria are no longer required to wear a lead apron during radiological imaging procedures such as X-ray and CT scans. However, the new recommendation, issued by…

Related articles