欢迎来到Shanghai GOM Testing & Technical Co,Ltd.官网! 中文版|English加入收藏|设为首页
专业认证,用心服务信誉第一、服务领先!
服务热线:021-34122669

Contact us

  • Contact:Dream Liu
  • Phone:021-34122669
  • Mobile:18018853504
  • QQ:1312447001
  • Address:NO. 609 Tahui Road,Shihudang Town,Songjiang District,Shanghai
  • MDD Certification位置:首页 > MDD Certification

    DIRECTIVE 93/42/EEC Medical Devices

    Scope

    This Directive shall apply to medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as medical devices in their own right. Both medical devices and accessories shall hereinafter be termed devices.

    This Directive does not apply to:

    (a) in vitro diagnostic devices;

    (b) active implantable devices covered by Directive 90/385/EEC;

    (c) medicinal products covered by Directive 65/65/EEC;

    (d) cosmetic products covered by Directive 76/76 8/EEC;

    (e) human blood, human blood products, human plasma or blood cells of human origin or to devices which incorporate at the time of placing on the market such blood products, plasma or cells;

    (f) transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin;

    (g) transplants or tissues or cells of animal origin, unless a device is manufactured utilizing animal tissue which is rendered non-viable or non-viable products derived from animal tissue.

    This Directive does not apply to personal protective equipment covered by Directive 89/686/EEC. In deciding whether a product falls under that Directive or the present Directive, particular account shall be taken of the principal intended purpose of the product.

    Classification

    1 . Devices shall be divided into Classes I, Ila, lib and III. Classification shall be carried out in accordance with Annex IX.

    2. In the event of a dispute between the manufacturer and the notified body concerned, resulting from the application of the classification rules, the matter shall be referred for decision to the competent authority to which the notified body is subject.

    3. The classification rules set out in Annex IX may be adapted in accordance with the procedure referred to in Article 7 (2) in the light of technical progress and any information which becomes available under the information system provided for in Article 10.

    Conformity assessment procedures

    1 . In the case of devices falling within Class III, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, either:

    (a) follow the procedure relating to the EC declaration of conformity set out in Annex II (full quality assurance); or

    (b) follow the procedure relating to the EC type-examination set out in Annex III, coupled

    with:

    (i) the procedure relating to the EC verification set

    out in Annex IV; or

    (ii) the procedure relating to the EC declaration of conformity set out in Annex V (production

    quality assurance).

    2. In the case of devices falling within Class Ila, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, follow the procedure relating to the EC declaration of conformity set out in Annex VII,

    coupled with either:

    (a) the procedure relating to the EC verification set out in Annex IV; or

    (b) the procedure relating to the EC declaration of conformity set out in Annex V (production quality assurance); or

    (c) the procedure relating to the EC declaration of conformity set out in Annex VI (product quality assurance).

    Instead of applying these procedures, the manufacturer may also follow the procedure referred to in paragraph 3 (a).

    3 . In the case of devices falling within Class lib, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, either:

    (a) follow the procedure relating to the EC declaration of conformity set out in Annex II (full quality assurance); in this case, point 4 of Annex II is not applicable; or

    (b) follow the procedure relating to the EC type-examination set out in Annex III, coupled with:

    (i) the procedure relating to the EC verification set out in Annex IV; or

    (ii) the procedure relating to the EC declaration of conformity set out in Annex V (production quality assurance); or

    (iii) the procedure relating to the EC declaration of conformity set out in Annex VI (product quality assurance).

    4. The Commission shall, no later than five years from the date of implementation of this Directive, submit a report to the Council on the operation of the provisions referred to in Article 10 ( 1 ), Article 15 ( 1 ), in particular in respect of Class I and Class Ila devices, and on the operation of the provisions referred to in Annex II, Section 4.3 second and third subparagraphs and in Annex III, Section 5 second and third subparagraphs to this Directive, accompanied, if necessary, by appropriate proposals.

    5. In the case of devices falling within Class I, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, follow the procedure referred to in Annex VII and draw up the EC declaration of conformity required before placing the device on the market.

    6. In the case of custom-made devices, the manufacturer shall follow the procedure referred to in Annex VIII and draw up the statement set out in that Annex before placing each device on the market. Member States may require that the manufacturer shall submit to the competent authority a list of such devices which have been put into service in their territory.

    7. During the conformity assessment procedure for a device, the manufacturer and/or the notified body shall take account of the results of any assessment and verification operations which, where appropriate, have been carried out in accordance with this Directive at an

    intermediate stage of manufacture.

    8. The manufacturer may instruct his authorized representative established in the Community to initiate the procedures provided for in Annexes III, IV, VII and VIII.

    9. Where the conformity assessment procedure involves the intervention of a notified body, the manufacturer, or his authorized representative established in the Community, may apply to a body of his choice within the framework of the tasks for which the body has been notified.

    10. The notified body may require, where duly justified, any information or data, which is necessary for establishing and maintaining the attestation of conformity in view of the chosen procedure.

    11 . Decisions taken by the notified bodies in accordance with Annexes II and III shall be valid for a maximum of five years and may be extended on application, made at a time agreed in the contract signed by both parties, for further periods of five years.

    12. The records and correspondence relating to the procedures referred to in paragraphs 1 to 6 shall be in an official language of the Member State in ^vhich the procedures are carried out and/or in another Community language acceptable to the notified body.

    13 . By derogation from paragraphs 1 to 6, the competent authorities may authorize, on duly justified request, the placing on the market and putting into service, within the territory of the Member State concerned, of individual devices for which the procedures referred to in paragraphs 1 to 6 have not been carried out and the use of which is in the interest of protection of health.

    CE marking

    1 . Devices, other than devices which are custom-made or intended for clinical investigations, considered to meet the essential requirements referred to in Article 3 must bear the CE marking of conformity when they are placed on the market.

    2. The CE marking of conformity, as shown in Annex XII, must appear in a visible, legible and indelible form on the device or its sterile pack, where practicable and appropriate, and on the instructions for use. Where applicable, the CE marking must also appear on the sales

    packaging.

    It shall be accompanied by the identification number of the notified body responsible for implementation of the procedures set out in Annexes II, IV, V and VI.

    3 . It is prohibited to affix marks or inscriptions which are likely to mislead third parties with regard to the meaning or the graphics of the CE marking. Any other mark may be affixed to the device, to the packaging or to the instruction leaflet accompanying the device provided that the visibility and legibility of the CE marking is not thereby reduced.


    Related documents download

    ESSENTIAL REQUIREMENTS OF MDD

    DIRECTIVE 93/42/EEC



    Shanghai GOM Testing & Technical Co.,Ltd., professional third-party certification company, provide you with an authoritative CE certification service, please contact us 021-34122669. 18018853503

    0