Search Legislation

Advanced Search

Council Directive 93/42/EECShow full title

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

Help about what version

What Version

Help about UK-EU Regulation

Legislation originating from the EU

When the UK left the EU, legislation.gov.uk published EU legislation that had been published by the EU up to IP completion day (31 December 2020 11.00 p.m.). On legislation.gov.uk, these items of legislation are kept up-to-date with any amendments made by the UK since then.

Close

This item of legislation originated from the EU

Legislation.gov.uk publishes the UK version. EUR-Lex publishes the EU version. The EU Exit Web Archive holds a snapshot of EUR-Lex’s version from IP completion day (31 December 2020 11.00 p.m.).

Status:

EU Directives are published on this site to aid cross referencing from UK legislation. Since IP completion day (31 December 2020 11.00 p.m.) no amendments have been applied to this version.

  1. Introductory Text

  2. Article 1.Definitions, scope

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

  4. Article 3.Essential requirements

  5. Article 4.Free movement, devices intended for special purposes

  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.Classification

  11. Article 10.Information on incidents occuring following placing of devices on the market

  12. Article 11.Conformity assessment procedures

  13. Article 12. Particular procedure for systems and procedure packs and procedure for sterilisation

  14. Article 12a. Reprocessing of medical devices

  15. Article 13. Decisions with regard to classification and derogation clause

  16. Article 14.Registration of persons responsible for placing devices on the market

  17. Article 14a. European databank

  18. Article 14b. Particular health monitoring measures

  19. Article 15.Clinical investigation

  20. Article 16.Notified bodies

  21. Article 17.CE marking

  22. Article 18.Wrongly affixed CE marking

  23. Article 19.Decision in respect of refusal or restriction

  24. Article 20. Confidentiality

  25. Article 20a. Cooperation

  26. Article 21.Repeal and amendment of Directives

  27. Article 22.Implementation, transitional provisions

  28. Article 23.This Directive is addressed to the Member States.

    1. ANNEX I

      ESSENTIAL REQUIREMENTS

      1. I. 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 achieve the performances intended by the manufacturer...

        4. 4. The characteristics and performances referred to in Sections 1, 2...

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

        6. 6. Any undesirable side-effect must constitute an acceptable risk when weighed...

        7. 6a. Demonstration of conformity with the essential requirements must include a...

      2. II. REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION

        1. 7. Chemical, physical and biological properties

          1. 7.1. The devices must be designed and manufactured in such a...

          2. 7.2. The devices must be designed, manufactured and packed in such...

          3. 7.3. The devices must be designed and manufactured in such a...

          4. 7.4. Where a device incorporates, as an integral part, a substance...

          5. 7.5. The devices must be designed and manufactured in such a...

          6. 7.6. Devices must be designed and manufactured in such a way...

        2. 8. Infection and microbial contamination

          1. 8.1. The devices and manufacturing processes must be designed in such...

          2. 8.2. Tissues of animal origin must originate from animals that have...

          3. 8.3. Devices delivered in a sterile state must be designed, manufactured...

          4. 8.4. Devices delivered in a sterile state must have been manufactured...

          5. 8.5. Devices intended to be sterilized must be manufactured in appropriately...

          6. 8.6. Packaging systems for non-sterile devices must keep the product without...

          7. 8.7. The packaging and/or label of the device must distinguish between...

        3. 9. Construction and environmental properties

          1. 9.1. If the device is intended for use in combination with...

          2. 9.2. Devices must be designed and manufactured in such a way...

          3. 9.3. Devices must be designed and manufactured in such a way...

        4. 10. Devices with a measuring function

          1. 10.1. Devices with a measuring function must be designed and manufactured...

          2. 10.2. The measurement, monitoring and display scale must be designed in...

          3. 10.3. The measurements made by devices with a measuring function must...

        5. 11. Protection against radiation

          1. 11.1. General

            1. 11.1.1. Devices shall be designed and manufactured in such a way...

          2. 11.2. Intended radiation

            1. 11.2.1. Where devices are designed to emit hazardous levels of radiation...

            2. 11.2.2. Where devices are intended to emit potentially hazardous, visible and/or...

          3. 11.3. Unintended radiation

            1. 11.3.1. Devices shall be designed and manufactured in such a way...

          4. 11.4. Instructions

            1. 11.4.1. The operating instructions for devices emitting radiation must give detailed...

          5. 11.5. Ionizing radiation

            1. 11.5.1. Devices intended to emit ionizing radiation must be designed and...

            2. 11.5.2. Devices emitting ionizing radiation intended for diagnostic radiology shall be...

            3. 11.5.3. Devices emitting ionizing radiation, intended for therapeutic radiology shall be...

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

          1. 12.1. Devices incorporating electronic programmable systems must be designed to ensure...

          2. 12.1a For devices which incorporate software or which are medical software...

          3. 12.2. Devices where the safety of the patients depends on an...

          4. 12.3. Devices where the safety of the patients depends on an...

          5. 12.4. Devices intended to monitor one or more clinical parameters of...

          6. 12.5. Devices must be designed and manufactured in such a way...

          7. 12.6. Protection against electrical risks

          8. 12.7. Protection against mechanical and thermal risks

            1. 12.7.1. Devices must be designed and manufactured in such a way...

            2. 12.7.2. Devices must be designed and manufactured in such a way...

            3. 12.7.3. Devices must be designed and manufactured in such a way...

            4. 12.7.4. Terminals and connectors to the electricity, gas or hydraulic and...

            5. 12.7.5. Accessible parts of the devices (excluding the parts or areas...

          9. 12.8. Protection against the risks posed to the patient by energy...

            1. 12.8.1. Devices for supplying the patient with energy or substances must...

            2. 12.8.2. Devices must be fitted with the means of preventing and/or...

          10. 12.9. The function of the controls and indicators must be clearly...

        7. 13. Information supplied by the manufacturer

          1. 13.1. Each device must be accompanied by the information needed to...

          2. 13.2. Where appropriate, this information should take the form of symbols....

          3. 13.3. The label must bear the following particulars:

          4. 13.4. If the intended purpose of the device is not obvious...

          5. 13.5. Wherever reasonable and practicable, the devices and detachable components must...

          6. 13.6. Where appropriate, the instructions for use must contain the following...

        8. 14. . . . . . . . . . ....

    2. ANNEX II

      EC DECLARATION OF CONFORMITY

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

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

      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 products...

        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. In addition to the obligations imposed by Section 3, the...

        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. 5. Surveillance

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

        2. 5.2. The manufacturer must authorize 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. Administrative provisions

        1. 6.1. The manufacturer or his authorised representative must, for a period...

        2. 6.2. . . . . . . . . . ....

        3. 6.3. . . . . . . . . . ....

      7. 7. Application to devices in Classes IIa and IIb.

        1. 7.1. In line with Article 11(2) and (3), this Annex may...

        2. 7.2. For devices in Class IIa the notified body shall assess,...

        3. 7.3. For devices in Class IIb the notified body shall assess,...

        4. 7.4. In choosing representative sample(s) the notified body shall take into...

        5. 7.5. Further samples shall be assessed by the notified body as...

      8. 8. Application to the devices referred to Article 1(4a)

    3. ANNEX III

      EC TYPE-EXAMINATION

      1. 1. EC type-examination is the procedure whereby a notified body ascertains...

      2. 2. The application includes:

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

      4. 4. The notified body must:

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

        2. 4.2. carry out or arrange for the appropriate inspections and the...

        3. 4.3. carry out or arrange for the appropriate inspections 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 applicant must inform the notified body which issued the...

      7. 7. Administrative provisions

        1. 7.1. . . . . . . . . . ....

        2. 7.2. Other notified bodies may obtain a copy of the EC...

        3. 7.3. The manufacturer or his authorised representative must keep with the...

        4. 7.4. . . . . . . . . . ....

    4. ANNEX IV

      EC VERIFICATION

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

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

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

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

      5. 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...

      6. 6. Statistical verification

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

        2. 6.2. A random sample is taken from each batch. The products...

        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. 7. Administrative provisions

      8. 8. Application to devices in Class IIa

        1. 8.1. in derogation from Sections 1 and 2, by virtue of...

        2. 8.2. in derogation from Sections 1, 2, 5 and 6, the...

      9. 9. Application to devices referred to in Article 1(4a)

    5. ANNEX V

      EC DECLARATION OF CONFORMITY

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

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

      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 products...

        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. Surveillance

        1. 4.1. The aim of surveillance is to ensure that the manufacturer...

        2. 4.2. The manufacturer authorizes the notified body to carry out all...

        3. 4.3. The notified body must periodically carry out appropriate inspections and...

        4. 4.4. In addition, the notified body may pay unannounced visits to...

      5. 5. Administrative provisions

        1. 5.1. The manufacturer or his authorised representative must, for a period...

        2. 5.2. . . . . . . . . . ....

      6. 6. Application to devices in Class IIa

        1. 6.1. By way of derogation from Sections 2, 3.1 and 3.2,...

        2. 6.2. For devices in Class IIa the notified body shall assess,...

        3. 6.3. In choosing representative sample(s) the notified body shall take into...

        4. 6.4. Further samples shall be assessed by the notified body as...

      7. 7. Application to devices referred to in Article 1(4a)

    6. ANNEX VI

      EC DECLARATION OF CONFORMITY

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

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

      3. 3. Quality system

        1. 3.1. The manufacturer lodges an application for assessment of his quality...

        2. 3.2. Under the quality system, each product or a representative sample...

        3. 3.3. The notified body audits the quality system to determine whether...

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

      4. 4. Surveillance

        1. 4.1. The aim of surveillance is to ensure that the manufacturer...

        2. 4.2. The manufacturer must allow the notified body access for inspection...

        3. 4.3. The notified body must periodically carry out appropriate inspections and...

        4. 4.4. In addition, the notified body may pay unannounced visits to...

      5. 5. Administrative provisions

        1. 5.1. The manufacturer or his authorised representative must, for a period...

        2. 5.2. . . . . . . . . . ....

      6. 6. Application to devices in Class IIa

        1. 6.1. By way of derogation from Sections 2, 3.1 and 3.2,...

        2. 6.2. For devices in Class IIa the notified body shall assess,...

        3. 6.3. In choosing representative sample(s) the notified body shall take into...

        4. 6.4. Further samples shall be assessed by the notified body as...

    7. ANNEX VII

      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 institute and keep up to date a...

      5. 5. With products placed on the market in sterile condition and...

      6. 6. Application to devices in Class IIa

        1. 6.1. where this Annex is applied in conjunction with the procedure...

    8. ANNEX VIII

      STATEMENT CONCERNING DEVICES FOR SPECIAL PURPOSES

      1. 1. For custom-made devices or for devices intended for clinical investigations...

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

        1. 2.1. for custom-made devices:

        2. 2.2. for devices intended for the clinical investigations covered by Annex...

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

        1. 3.1. For custom-made devices, documentation, indicating manufacturing site(s) and allowing an...

        2. 3.2. For devices intended for clinical investigations, the documentation must contain:...

      4. 4. The information contained in the declarations concerned by this Annex...

      5. 5. For custom-made devices, the manufacturer must undertake to review and...

    9. ANNEX IX

      CLASSIFICATION CRITERIA

      1. I. DEFINITIONS

        1. 1. Definitions for the classification rules

          1. 1.1. Duration

            1. Transient

            2. Short term

            3. Long term

          2. 1.2. Invasive devices

            1. Invasive device

            2. Body orifice

            3. Surgically invasive device

            4. Implantable device

          3. 1.3. Reusable surgical instrument

          4. 1.4. Active medical device

          5. 1.5. Active therapeutical device

          6. 1.6. Active device for diagnosis

          7. 1.7. Central circulatory system

          8. 1.8. Central nervous system

      2. II. IMPLEMENTING RULES

        1. 2. Implementing rules

          1. 2.1. Application of the classification rules shall be governed by the...

          2. 2.2. If the device is intended to be used in combination...

          3. 2.3. Software, which drives a device or influences the use of...

          4. 2.4. If the device is not intended to be used solely...

          5. 2.5. If several rules apply to the same device, based on...

          6. 2.6. In calculating the duration referred to in Section 1.1 of...

      3. III. CLASSIFICATION

        1. 1. Non-invasive devices

          1. 1.1. Rule 1

          2. 1.2. Rule 2

          3. 1.3. Rule 3

          4. 1.4. Rule 4

        2. 2. Invasive devices

          1. 2.1. Rule 5

          2. 2.2. Rule 6

          3. 2.3. Rule 7

          4. 2.4. Rule 8

        3. 3. Additional rules applicable to active devices

          1. 3.1. Rule 9

          2. 3.2. Rule 10

            1. Rule 11

          3. 3.3. Rule 12

        4. 4. Special Rules

          1. 4.1. Rule 13

          2. 4.2. Rule 14

          3. 4.3. Rule 15

          4. 4.4. Rule 16

          5. 4.5. Rule 17

        5. 5. Rule 18

    10. ANNEX X

      CLINICAL EVALUATION

      1. 1. General provisions

        1. 1.1. As a general rule, confirmation of conformity with the requirements...

          1. 1.1.1. Either a critical evaluation of the relevant scientific literature currently...

          2. 1.1.2. Or a critical evaluation of the results of all clinical...

          3. 1.1.3. Or a critical evaluation of the combined clinical data provided...

        2. 1.1a In the case of implantable devices and devices in Class...

        3. 1.1b The clinical evaluation and its outcome shall be documented. This...

        4. 1.1c The clinical evaluation and its documentation must be actively updated...

        5. 1.1d Where demonstration of conformity with essential requirements based on clinical...

        6. 1.2. All the data must remain confidential, in accordance with the...

      2. 2. Clinical investigations

        1. 2.1. Objectives

        2. 2.2. Ethical considerations

        3. 2.3. Methods

          1. 2.3.1. Clinical investigations must be performed on the basis of an...

          2. 2.3.2. The procedures used to perform the investigations must be appropriate...

          3. 2.3.3. Clinical investigations must be performed in circumstances similar to the...

          4. 2.3.4. All the appropriate features, including those involving the safety and...

          5. 2.3.5. All serious adverse events must be fully recorded and immediately...

          6. 2.3.6. The investigations must be performed under the responsibility of a...

          7. 2.3.7. The written report, signed by the medical practitioner or other...

    11. ANNEX XI

      CRITERIA TO BE MET 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 notified body must have:

      5. 5. The impartiality of the notified body must be guaranteed. Their...

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

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

    12. ANNEX XII

      CE MARKING OF CONFORMITY

      1. The CE conformity marking shall consist of the initials ‘CE’...

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

Back to top

Options/Help

Print Options

You have chosen to open the Whole Directive

The Whole Directive you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.

Would you like to continue?

You have chosen to open Schedules only

The Schedules you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.

Would you like to continue?

Close

Legislation is available in different versions:

Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.

Original (As adopted by EU): The original version of the legislation as it stood when it was first adopted in the EU. No changes have been applied to the text.

Close

Opening Options

Different options to open legislation in order to view more content on screen at once

Close

More Resources

Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as adopted version that was used for the EU Official Journal
  • lists of changes made by and/or affecting this legislation item
  • all formats of all associated documents
  • correction slips
  • links to related legislation and further information resources
Close

Timeline of Changes

This timeline shows the different versions taken from EUR-Lex before exit day and during the implementation period as well as any subsequent versions created after the implementation period as a result of changes made by UK legislation.

The dates for the EU versions are taken from the document dates on EUR-Lex and may not always coincide with when the changes came into force for the document.

For any versions created after the implementation period as a result of changes made by UK legislation the date will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. For further information see our guide to revised legislation on Understanding Legislation.

Close

More Resources

Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as adopted version that was used for the print copy
  • correction slips

Click 'View More' or select 'More Resources' tab for additional information including:

  • lists of changes made by and/or affecting this legislation item
  • confers power and blanket amendment details
  • all formats of all associated documents
  • links to related legislation and further information resources

The data on this page is available in the alternative data formats listed: