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Active implantable medical devices

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Active implantable medical devices

This Directive aims to harmonise and improve the level of safety to be met by active implantable medical devices used in human medicine. It 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 the protection of the health and safety of patients.

ACT

Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices [See amending acts].

SUMMARY

This Directive shall apply to active implantable medical devices .

It shall not apply to:

  • medicinal products for human use;
  • human blood, blood products, plasma or blood cells of human origin or to devices which contain them at the time of placing on the market;
  • transplants, tissues or cells of human origin or to products incorporating them or derived from them;
  • transplants, tissues or 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

Active implantable medical devices must meet the essential requirements contained in Annex I of the Directive, i.e. the necessary measures to ensure a high level of safety and performance of these devices. They must not compromise the clinical condition or the safety of patients and neither must they present any risk to the persons implanting them, or to other persons.

They must also achieve the performances intended by the manufacturer. In addition to the general requirements set out above, these essential requirements mainly relate to the design and manufacture of devices, including the packaging and instructions accompanying each device, which can now, in certain cases and under certain conditions, be provided in electronic form.

Harmonised standards

To facilitate proof of conformity with the essential requirements and to allow this conformity to be checked, the Directive provides for the establishment of harmonised standards at European level, which are drawn up by the European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardization (Cenelec).

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

Any product manufactured in accordance with harmonised standards is presumed to conform to the essential requirements.

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.

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, which 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.

REFERENCES

Act

Entry into force

Deadline for transposition in the Member States

Official Journal

Directive 90/385/EEC

1.1.1993

1.7.1992

OJ L 189 of 20.7.1990

Amending act(s)

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

Directive 93/68/EEC

1.1.1995

1.7.1994

OJ L 220 of 30.8.1993

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

Regulation (EU) No 207/2012

30.3.2012

-

OJ L 72 of 10.3.2012

Successive amendments and corrections to Directive 90/385/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].

Databank

Commission Decision 2010/227/EU of 19 April 2010 on the European Databank on Medical Devices (Eudamed) [Official Journal L 102 of 23.4.2010].

Member States shall ensure that data on medical devices are entered into the Eudamed databank.

Notified bodies

The Nando database will enable you to find the European notified bodies as well as certain third country bodies which are responsible for carrying out the conformity assessment procedures referred to in the New Approach directives.

Last updated: 10.04.2014

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