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Directive 98/79/EC of the European Parliament and of the CouncilShow full title

Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices

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EU Directives are being published on this site to aid cross referencing from UK legislation. After IP completion day (31 December 2020 11pm) no further amendments will be applied to this version.

  1. Introductory Text

  2. Article 1.Scope, definitions

  3. Article 2.Placing on the market and putting into service

  4. Article 3.Essential requirements

  5. Article 4.Free movement

  6. Article 5.Reference to standards

  7. Article 6. Committee on Standards and Technical Regulations

  8. Article 7.(1) The Commission shall be assisted by the Committee set...

  9. Article 8.Safeguard clause

  10. Article 9.Conformity assessment procedures

  11. Article 10.Registration of manufacturers and devices

  12. Article 11.Vigilance procedure

  13. Article 12.European databank

  14. Article 13.Where a Member State considers, in relation to a given...

  15. Article 14.Amendments to Annex II, and derogation clause

  16. Article 15.Notified bodies

  17. Article 16.CE marking

  18. Article 17.Wrongly affixed CE marking

  19. Article 18.Decisions in respect of refusal or restriction

  20. Article 19.Confidentiality

  21. Article 20.Cooperation between Member States

  22. Article 21.Amendment of directives

  23. Article 22.Implementation, transitional provisions

  24. Article 23.This Directive shall enter into force on the day of...

  25. Article 24.This Directive is addressed to the Member States.

    1. ANNEX I

      ESSENTIAL REQUIREMENTS

      1. A. GENERAL REQUIREMENTS

        1. 1. The devices must be designed and manufactured in such a...

        2. 2. The solutions adopted by the manufacturer for the design and...

        3. 3. The devices must be designed and manufactured in such a...

        4. 4. The characteristics and performances referred to in sections 1 and...

        5. 5. The devices must be designed, manufactured and packed in such...

      2. B. DESIGN AND MANUFACTURING REQUIREMENTS

        1. 1. Chemical and physical properties

          1. 1.1. The devices must be designed and manufactured in such a...

          2. 1.2. The devices must be designed, manufactured and packed in such...

        2. 2. Infection and microbial contamination

          1. 2.1. The devices and their manufacturing processes must be designed in...

          2. 2.2 Where a device incorporates biological substances, the risks of infection...

          3. 2.3. Devices labelled either as ‘STERILE’ or as having a special...

          4. 2.4. Devices labelled either as ‘STERILE’ or as having a special...

          5. 2.5. Packaging systems for devices other than those referred to in...

          6. 2.6. Devices intended to be sterilised must be manufactured in appropriately...

          7. 2.7. Packaging systems for non-sterile devices must keep the product without...

        3. 3. Manufacturing and environmental properties

          1. 3.1. If the device is intended for use in combination with...

          2. 3.2. Devices must be designed and manufactured in such a way...

          3. 3.3. Devices must be designed and manufactured in such a way...

          4. 3.4. Devices must be designed and manufactured in such a way...

          5. 3.5. Devices must be designed and manufactured in such a way...

          6. 3.6. The measuring, monitoring or display scale (including colour change and...

        4. 4. Devices which are instruments or apparatus with a measuring function...

          1. 4.1. Devices which are instruments or apparatus having a primary analytical...

          2. 4.2. When values are expressed numerically, they must be given in...

        5. 5. Protection against radiation

          1. 5.1. Devices shall be designed, manufactured and packaged in such a...

          2. 5.2. When devices are intended to emit potentially hazardous, visible and/or...

          3. 5.3. The operating instructions for devices emitting radiation must give detailed...

        6. 6. Requirements for medical devices connected to or equipped with an...

          1. 6.1. Devices incorporating electronic programmable systems, including software, must be designed...

          2. 6.2. Devices must be designed and manufactured in such a way...

          3. 6.3. Devices must be designed and manufactured in such a way...

          4. 6.4. Protection against mechanical and thermal risks

            1. 6.4.1. Devices must be designed and manufactured in such a way...

            2. 6.4.2. Devices must be designed and manufactured in such a way...

            3. 6.4.3. Devices must be designed and manufactured in such a way...

            4. 6.4.4. Terminals and connectors to electricity, gas or hydraulic and pneumatic...

            5. 6.4.5. Accessible parts of the devices (excluding the parts of areas...

        7. 7. Requirements for devices for self-testing

          1. 7.1. Devices for self-testing must be designed and manufactured in such...

          2. 7.2. Devices for self-testing must, where reasonably possible, include user control,...

        8. 8. Information supplied by the manufacturer

          1. 8.1. Each device must be accompanied by the information needed to...

          2. 8.2. Where appropriate, the information to be supplied should take the...

          3. 8.3. In the case of devices containing or a preparation which...

          4. 8.4. The label must bear the following particulars which may take...

          5. 8.5. If the intended purpose of the device is not obvious...

          6. 8.6. Wherever reasonable and practicable, the devices and separate components must...

          7. 8.7. Where appropriate, the instructions for use must contain the following...

    2. ANNEX II

      LIST OF DEVICES REFERRED TO IN ARTICLE 9(2) AND (3)

      1. List A

      2. Reagents and reagent products, including related calibrators and control materials,...

      3. List B

      4. Reagents and reagent products, including related calibrators and control materials,...

    3. ANNEX III

      EC DECLARATION OF CONFORMITY

      1. 1. The EC declaration of conformity is the procedure whereby the...

      2. 2. The manufacturer must prepare the technical documentation described in section...

      3. 3. The technical documentation must allow assessment of the conformity of...

      4. 4. The manufacturer shall take necessary measures to ensure that the...

      5. 5. The manufacturer shall institute and keep up to date a...

      6. 6. For devices for self-testing the manufacturer shall lodge an application...

        1. 6.1. The application shall enable the design of the device to...

        2. 6.2. The notified body shall examine the application and, if the...

        3. 6.3. The applicant shall inform the notified body which issued the...

    4. ANNEX IV

      EC DECLARATION OF CONFORMITY

      1. 1. The manufacturer must ensure application of the quality system approved...

      2. 2. The declaration of conformity is the procedure whereby the manufacturer...

      3. 3. Quality system

        1. 3.1. The manufacturer must lodge an application for assessment of his...

        2. 3.2. Application of the quality system must ensure that the devices...

        3. 3.3. The notified body must audit the quality system to determine...

        4. 3.4. The manufacturer must inform the notified body which approved the...

      4. 4. Examination of the design of the product

        1. 4.1. For devices covered by Annex II, List A, in addition...

        2. 4.2. The application must describe the design, manufacture and performances of...

        3. 4.3. The notified body must examine the application and, if the...

        4. 4.4. Changes to the approved design must receive further approval from...

        5. 4.5. The manufacturer shall inform the notified body without delay if...

      5. 5. Surveillance

        1. 5.1. The aim of surveillance is to ensure that the manufacturer...

        2. 5.2. The manufacturer must authorise the notified body to carry out...

        3. 5.3. The notified body must periodically carry out appropriate inspections and...

        4. 5.4. In addition, the notified body may pay unannounced visits to...

      6. 6. Verification of manufactured products covered by Annex II, List A...

        1. 6.1. In the case of devices covered by Annex II, List...

        2. 6.2. The manufacturer may place the devices on the market, unless...

    5. ANNEX V

      EC TYPE-EXAMINATION

      1. 1. EC type-examination is the part of the procedure whereby a...

      2. 2. The application for EC type-examination shall be lodged by the...

      3. 3. The documentation must allow an understanding of the design, the...

      4. 4. The notified body shall:

        1. 4.1. examine and assess the documentation and verify that the type...

        2. 4.2. perform or have performed appropriate examinations and the tests necessary...

        3. 4.3. carry out or ask for the appropriate examinations and the...

        4. 4.4. agree with the applicant on the place where the necessary...

      5. 5. If the type conforms to the provisions of this Directive,...

      6. 6. The manufacturer shall inform the notified body without delay if...

        1. 6.1. Changes to the approved device must receive further approval from...

      7. 7. Administrative provisions

    6. ANNEX VI

      EC VERIFICATION

      1. 1. EC verification is the procedure whereby the manufacturer or his...

      2. 2.1. The manufacturer must take all the measures necessary to ensure...

      3. 2.2. To the extent that for certain aspects the final testing...

      4. 3. The manufacturer must undertake to institute and keep up to...

      5. 4. The notified body must carry out the appropriate examinations and...

      6. 5. Verification by examination and testing of every product

        1. 5.1. Every product is examined individually and the appropriate tests defined...

        2. 5.2. The notified body must affix, or have affixed, its identification...

      7. 6. Statistical verification

        1. 6.1. The manufacturer must present the manufactured products in the form...

        2. 6.2. One or more random samples, as necessary, are taken from...

        3. 6.3. Statistical control of products will be based on attributes and/or...

        4. 6.4. If the batch is accepted, the notified body affixes, or...

    7. ANNEX VII

      EC DECLARATION OF CONFORMITY

      1. 1. The manufacturer must ensure application of the quality system approved...

      2. 2. The declaration of conformity is the part of the procedure...

      3. 3. Quality system

        1. 3.1. The manufacturer must lodge an application for assessment of his...

        2. 3.2. Application of the quality system must ensure that the devices...

        3. 3.3. The notified body must audit the quality system to determine...

        4. 3.4. The manufacturer shall inform the notified body which approved the...

      4. 4. Surveillance

      5. 5. Verification of manufactured products covered by Annex II, List A...

        1. 5.1. In the case of devices covered by Annex II, List...

        2. 5.2. The manufacturer may place the devices on the market, unless...

    8. ANNEX VIII

      STATEMENT AND PROCEDURES CONCERNING DEVICES FOR PERFORMANCE EVALUATION

      1. 1. For devices for performance evaluation the manufacturer or his authorised...

      2. 2. The statement shall contain the following information:

      3. 3. The manufacturer shall also undertake to keep available for the...

      4. 4. The provisions of Article 10(1), (3) and (5) shall apply...

    9. ANNEX IX

      CRITERIA FOR THE DESIGNATION OF NOTIFIED BODIES

      1. 1. The notified body, its director and the assessment and verification...

      2. 2. The notified body and its staff must carry out the...

      3. 3. The notified body must be able to carry out all...

      4. 4. The inspection staff must have:

      5. 5. The impartiality of the inspection staff must be guaranteed. Their...

      6. 6. The body must take out civil liability insurance, unless liability...

      7. 7. The staff of the inspection body are bound to observe...

    10. ANNEX X

      CE MARKING OF CONFORMITY

      1. If the marking is reduced or enlarged the proportions given...

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