Magazine article Information Today

ECRI and IDEM Issue European Union Legal and Regulatory Information on CD

Magazine article Information Today

ECRI and IDEM Issue European Union Legal and Regulatory Information on CD

Article excerpt

Two CD-ROMs that provide information of interest to those wishing to conduct business in the European Union have recently become available. ECRI, a nonprofit health services research agency and a Collaborating Center of the World Health Organization, has issued a CD-ROM to help manufacturers of medical devices satisfy the necessary requirements before they can sell their products within the European Union. The second product, the Information Desk of Enterprise Mobility (IDEM), is a database on the legal and practical aspects of establishing companies in six countries of the European Union.

INBIT's Medical Devices Directive

Before selling medical devices within the European Union, manufacturers must assign a risk class to the devices and follow other safety and performance requirements defined by the Medical Devices Directive. Certification that these requirements have been met can be performed by one of the European standards organizations; a government-appointed product certification body; or the manufacturer itself, which can self-certify the products.

To help manufacturers who want to self-certify their own products by meeting the classification requirements of the Directive, the Institute of Biomedical Technology (INBIT), a nonprofit organization headquartered in Greece, has produced a CD-ROM that is composed of two applications: 1) the full text of the European Medical Devices Directive, and 2) a Medical Device Classification Guide for determining the risk level of a device.

The first part of the CD-ROM, the Medical Devices Directive, is a concise electronic directory of the European Union regulations for medical devices, with search-and-retrieval capabilities. Keyword and free-text search facilities allow rapid access to any part of the text of the official European Union documents. The directory contains the latest versions of the Medical Devices Directive, accompanied by working documents, the Guidelines for the Medical Device Vigilance System, and Classification Rules -- all available in English.

The Medical Device Classification Guide, the second part of the CD-ROM, assists with the classification of medical devices into four risk classes by providing an electronic decision tree. …

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