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Brief Introduction of
EU Council Directive 93/42/EEC
Medical Devices

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The main purpose of New Approach Directives is to bring about the completion of the single market by introducing harmonized and statutorily based controls to regulate the safety and marketing of products throughout the European Union (EU).

There are two Medical Device Directives in place, the Active Implantable Medical Devices Directive (90/385/EEC) and the Medical Devices Directive (93/42/EEC), the third, covering In Vitro Diagnostic Devices is available in draft form.

In common with other New Approach Directives, the two Medical Device Directives in place include provisions for mandatory CE Marking of all products covered by them.

The scope of the notifications are as follows : -

Medical Devices Directive (93/42/EEC)

  • Annex II Full Quality Assurance
  • Annex V Production Quality Assurance
  • Annex VI Product Quality Assurance

Active Implantable Medical Devices Directive (90/385/EEC)

  • Annex II Full Quality Assurance
  • Annex V Production Quality Assurance

    The content of this page deals only with the Medical Devices Directive (93/42/EEC).

    Overview

    A Medical Device is defined in Directive (93/42/EEC) as ; Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for the proper application, intended by the manufacturer to be used for human beings for the purpose of :

    • diagnosis, prevention, monitoring, treatment or alleviation of a disease, an injury or a handicap.
    • investigation, replacement or modification of the anatomy or of a physiological process.
    • control of conception

    and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted by such means. The Directive gives additional definitions of relevant devices and terms. The following products are excluded from the scope of the Directive :

    • In vitro diagnostic devices
    • Active implantable devices covered by Directive 90/385/EEC
    • Medicinal products covered by Directive 65/65/EEC
    • Cosmetic products covered by Directive 76/768/EEC
    • Personal protective equipment covered by Directive 89/686/EEC
    • Tissues or cells of human origin
    • Viable tissue or cells of animal origin.

    The Directive sets out the classification criteria for Medical Devices and outlines the appropriate conformity assessment procedures for each class of device.

    The Medical Device Directive came into effect on 1st January, 1995

    A transitional period, up to 13rd June 1998, within which manufacturers may choose either to apply CE Marking under the terms of the Directive or to conform to specific national regulations allowing product to be marketed only where such national regulations are accepted, is given in the Directive.

    All devices being put on the market in the EU after 13rd June 1998 must bear CE Marking.

    Competent Authority

    Under the terms of the Medical Device Directive a competent authority is nominated by the Government of each member state to monitor and ensure compliance with its provisions. The Competent Authority is responsible for ;

    • designating Notified Bodies to carry out conformity assessment procedures.
    • handling applications for clinical investigations.
    • ensuring adverse incidents are reported within appropriate time scales and evaluated.
    • the withdrawal of unsafe devices from the market.
    • effecting the Directives into law through statutory instruments.
    • ensuring only those devices bearing the CE marking are allowed onto the market.

    Medical devices, bearing the CE marking, are presumed to conform to the appropriate essential requirements, unless there is reason to believe otherwise. Should this be the case, the Competent Authority will take appropriate measures which may include withdrawal from the market. The Competent Authority must inform the European Commission of any enforcement action taken.

    Notified Body

    The organization which will check whether the appropriate conformity assessment procedures have been followed is known as the Notified Body. It is a certification organization which the Competent Authority, of a Member State designates to carry out one or more of the conformity assessment procedures described in the annexes of the Directives. A Notified Body must be qualified to perform all the functions set out in any annex for which it is designated. The Directive lays down criteria for the Competent Authority to assess whether certification organizations are sufficiently qualified to act as Notified Bodies. They may do this only for organizations under its own jurisdiction. The Competent Authority must notify the European Commission of those bodies selected. These will appear in the Official Journal of the European Communities. The selection criteria ensure impartiality and expertise of prospective Notified Bodies. Periodic auditing of the Notified Body by the Competent Authority, will ensure adherence to these criteria. A Notified Body will not necessarily have to carry out every part of the testing or auditing, some aspects may be subcontracted. In such cases, the Notified Body must retain the final and overall responsibility.

    The scope of the notifications are as follows : -

    Medical Devices Directive (93/42/EEC)

    • Annex II Full Quality Assurance
    • Annex V Production Quality Assurance
    • Annex VI Product Quality Assurance

    Conformity Assessment Procedures

    The conformity assessment procedures are the routes available under the Medical Devices Directives, for manufacturers to demonstrate that their devices meet the Essential Requirements, thus enabling the CE marking to be affixed to the device. Having classified the device according to its properties, function and intended purpose, devices will be assigned to one of 4 Classes ;

    Class I

    low risk devices

    Class II(a) and Class II(b)

    medium risk devices

    Class III

    high risk devices

    The main purpose is to allow the strictest controls to be applied only to those devices which present the greatest risk to health or safety. Conformity assessment routes for each class are set out in the Directive and these are shown generically on Flowchart No. 1. Details on the various options available to the manufacturer for different classes of devices are set out in Flowchart No抯.( 2 through 7 ). In assessing the Quality Management System element in conformity assessment some notified body has adopted the EN 46000 series of standards, particular requirements for Medical Device manufacturers in addition to the ISO 9000 Series.

    GUIDE TO CE MARKING

    Step 1 Classify your products according to Annex IX of Directive.
    Step 2 Decide on your conformity assessment route (Annexes). The following options are open to you.

    Class I
    Sterile / Measuring
    Annex VII + Annex V
    for Sterile / Measuring aspects
    Class II a Annex II
    Annex VII + V
    Annex VII + VI
    Class II b Annex II
    Annex III + V
    Annex III + VI
    Class III Annex II
    Annex III + V

    Step 3 Follow TDe procedures detailed in TDe following pages for TDe selected Annexes.

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