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Accreditation of Medical Laboratories in Europe: Statutory Framework, Current Situation and Perspectives

Due to economic and technological changes in laboratory medicine that go along with new regulatory requirements in the field of medical devices, the implementation of quality systems in medical laboratories has broadly expanded within Europe during the last decade. In the context of the New Approach, the competence of medical laboratories is of decisive importance for premarket conformity assessment of medical devices including in vitro diagnostics and should be confirmed by accreditation. Although EN ISO/IEC 17025 and EN ISO 15189 provide useful requirements for laboratory testing, these standards are insufficient for giving full presumption of conformity in connection with requirements set by European directives. Additional regulatory documents and standards as the CTS and EN 13612 should be considered. Although accreditation in most European countries is voluntary, the requirement for implementation of quality management systems in medical laboratories has been introduced into the national legislation of many Central and Western European countries. Along with this development, accreditation according to EN ISO/IEC 17025 and, since 2003 according to EN ISO 15189, constitutes the main external quality assessment procedure for medical laboratories. Perspectives for accreditation will mainly be influenced by the currently performed changes of the medical devices directive 93/42/EEC and the review of the New Approach.