NIST GCR 01-815 A Guide to the EU Medical Device Directive

Helen Delaney and Rene van de Zande, Co-Editors Global Standards Program Office of Standards Services National Institute of Standardsand Technology Gaithersburg MD 20899-2100 Order No. 43SBNB060086

July 2001

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ABSTRACT
This guide (prepared under contract by Helen Delaney and Rene van de Zande, DVZ Joint Ventures) is aneasy-to-use introductory reference for industry and government officials on the requirements of the European Union’s (EU) Medical Device Directive (MDD) 93/42/EEC]. It is designed to help businessand government officials understand the purpose of the directive, its relationship to other directives, the essential requirements contained in the directive, and the basic steps necessary forcompliance. The guide offers explanations of such requirements as: the products covered by the directive, the products excluded from coverage under the directives, and issues regarding device classificationand the use of standards. The guide contains the text of the directive and a list of applicable standards. The guide also references appropriate sections of NIST Special Publication 951: A Guide toEU Standards and Conformity Assessment for further information on some of the generic conformity assessment concepts and requirements of the EU’s New Approach.

Key Words: CEN; CENELEC; conformityassessment; device classification; directives; European Union; Medical Device Directive; medical devices; New Approach directives; pharmaceuticals; technical construction files; user manuals;

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Contents
To Be Considered: -------------------------------------------1 Purpose of the Medical Device Directive ---------------------2 Basic Steps to Compliance-----------------------------------2 I. 2 II. 3 III. 16 IV. 17 V. 20 VI. 21 VII. 22 VIII. Vigilance System ---------------------------------22 IX. 24 X. Authorized Representation and Competent Authority Registration... [continua]

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