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Medical devices

This directive aims to harmonise the conditions governing the movement, the placing on the market and the bringing into service of medical devices throughout the internal market. The directive is based on the principles of the "New Approach to Technical Harmonisation and Standards". In line with this new approach, the design and manufacture of medical devices is subject to essential requirements concerning protection of the health and safety of patients and users of these devices.

ACT

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices [See amending acts].

SUMMARY

This directive applies to medical devices * and their accessories *.

Scope

It does not apply to:

  • devices used for in vitro diagnosis ;
  • active implantable devices ;
  • medicinal products for human use , including medicinal products derived from blood;
  • cosmetic products;
  • partly to human blood , blood products , 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 with the exception of devices referred to in paragraph 4a;
  • transplants, tissues and cells of human origin or to products incorporating or derived from tissues or cells of human origin with the exception of devices referred to in paragraph 4a;
  • transplants, tissues and cells of animal origin, unless a device is manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue.

Essential requirements

Medical devices must not compromise the clinical condition or the safety of patients. In addition, they must not present any risk to the persons implanting them, or to other persons.

These devices must achieve the performances intended by the manufacturer. They must be designed in such a way as to withstand the storage and transport conditions.

Harmonised standards

Member States shall publish the national standards implementing the corresponding harmonised standards, which shall also include the monographs of the European Pharmacopoeia.

Member States shall assume that devices meet the essential safety requirements set out in this Directive where the devices comply with the national standards transposing the relevant applicable harmonised standards.

Conformity procedures

All devices must be subjected to a conformity assessment procedure. Member States shall designate independent bodies contributing to the application of these procedures for devices other than those which represent a minimal risk.

Placing on the market and free movement

Member States shall take necessary steps to ensure that devices may be placed on the market and put into service only if they meet the requirements of this Directive and do not compromise the safety and health of patients, users and other persons when properly implanted, maintained and used in accordance with their intended purposes.

Member States not must not impede the placing on the market, free movement and putting into service of devices meeting the essential safety criteria set out in the annexes to the Directive and bearing the CE mark.

European databank

The aim of the European databank is to store the data required by law. The latter shall be made available to the competent authorities and shall contain:

  • data on registration of manufacturers;
  • data relating to certificates issued, amended, suspended, withdrawn or refused;
  • data obtained in accordance with the vigilance procedure;
  • data on clinical investigations.

Vigilance

The manufacturer must immediately inform the competent authorities of any incident causing death or damage to the health of a patient, by applying the procedures of a technico-vigilance system. This information must be recorded and evaluated by Member States.

Surveillance

Notified bodies shall be authorised to carry out inspections of manufacturers. For their part, manufacturers must provide the inspectors with all relevant information.

Safeguard measures

Member States must take all appropriate measures to withdraw from the market devices conforming to the Directive which are liable to compromise the health and/or safety of patients, users or third parties. The provisional measures taken must be notified to the Commission.

Key terms used in the act
  • 'medical device' means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:
    1. diagnosis, prevention, monitoring, treatment or alleviation of disease;
    2. diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;
    3. investigation, replacement or modification of the anatomy or of a physiological process;
    4. 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 in its function by such means.
  • 'accessory' means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device.

REFERENCES

Act Entry into force Deadline for transposition in the Member States Official Journal

Directive 93/42/EEC

12.7.1993

1.7.1994

OJ L 169 of 12.7.1993

Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Directive 98/79/EC

7.12.1998

7.12.1999

OJ L 331 of 7.12.1998

Directive 2000/70/EC

13.12.2000

13.12.2001

OJ L 313 of 13.12.2000

Directive 2001/104/EC

10.1.2002

13.12.2001

OJ L 6 of 10.1.2002

Regulation (EC) No 1882/2003

20.11.2003

-

OJ L 284 of 31.10.2003

Directive 2007/47/EC

11.10.2007

21.12.2007

OJ L 247 of 21.9.2007

Successive amendments and corrections to Directive 93/42/EEC have been incorporated into the basic text. This consolidated version is for information only.

RELATED ACTS

Particular requirements

Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin (Text with EEA relevance) [Official Journal L 212 of 9.8.2012].

Joint replacements

Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices [Official Journal L 210 of 12.8.2005].

Breast implants

Commission Directive 2003/12/EC of 3 February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices [Official Journal L 28 of 4.2.2003].
In order to ensure the highest possible level of safety for breast implants, these are reclassified as Class III medical devices.

Tissues of animal origin:

Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin [Official Journal L 105 of 26.4.2003].
The Directive aims to improve the level of safety and health protection by further reinforcing the protective measures against the overall risk of transmitting animal spongiform encephalopathies.

Last updated: 27.12.2012

See also

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