A European quality management system standard for the medical device industry. Technically equivalent to ISO 13485:1996, an international medical device standard.

EN 46000, the Medical Device Quality Management Systems Standard, addresses the particular concerns of the medical devices industry in interpreting and implementing ISO 9000. Published in 1994, the standard provides medical device manufacturers, distributors, importers, assemblers, component manufacturers and service organizations with an industry-specific quality management system. EN 46000 must be used in combination with ISO 9001.

EN 46000 embraces the principles of good manufacturing practice, commonly used in medical device manufacture. It offers its users an auditing process similar to a quality management systems audit. The standard also helps users market their products throughout the EU because its conformity assessment process under the Medical Device Directive 93/42/EEC permits CE marking. Conversely, if a company wants to be CE compliant, it must also comply with EN 46000.

EN 46000 is technically equivalent to ISO 13485:1996, an international medical device standard. So few differences exist between the two that if an organization is prepared to comply with one, it may easily comply with the other as well.

Contact: BSI Standards Dept., UK Desk, 389 Chiswick High Road, London, W4 4AL, United Kingdom; telephone 44-181-996-9001; fax 44-181-996-7001; e-mail info@bsi.org.uk; Web www.bsi.org.uk