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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 Standards and Technology Gaithersburg MD 20899-2100 Order No. 43SBNB060086

July 2001


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 business and 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 for compliance.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 classification and 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 to EUStandards 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; conformity assessment; device classification; directives; European Union; Medical Device Directive; medical devices; New Approach directives; pharmaceuticals; technical construction files; user manuals;


iv 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-------------------------------------25 CE Marking ---------------------------------------Declaration of Conformity ------------------------EC Verification by Notified Body -----------------Technical File -----------------------------------Risk Analysis ------------------------------------Compliance to the Essential Requirements of the Directive ----------------------------------------Harmonized Standards-----------------------------Conformity Assessment Routes ---------------------Determining Whether or Not the Product Has To Comply with the Medical Device Directive ----------------Classification of the Medical Device --------------

XI. 25 XII. 25


Text of Directive 93/42/EEC ---------------------------------27 Annex I Essential Requirements ----------------------47 Annex II EC Declaration ofConformity ----------------56 Annex III EC Type Examination -------------------------61 Annex IV EC Verification -----------------------------64 Annex V EC Declaration of Conformity ----------------67 Annex VI EC Declaration of Conformity ----------------71 Annex VII EC Declaration of Conformity ----------------75 Annex VIII Statement Concerning Devices for Special Purposes----------------------------77 Annex IX Classification Criteria ---------------------79 Annex X Clinical Evaluation -------------------------86 Annex XI Criteria to be Met for the Designation of Notified Bodies -----------------------------88 Annex XII CE Marking of Conformity --------------------90 Medical devices classification guidance chart: Non Invasive Devices -----------------------------------------------------91Medical devices classification guidance chart: Invasive Devices -----------------------------------------------------92 Medical devices classification guidance chart: Active Devices -----------------------------------------------------94

Medical Device Harmonized Standards -------------------------95


The Medical Device Directive1 2 3
Directive 93/42/EEC Applicable since June...
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